Product Code: KIR FDA class 1 21 CFR 864.2280

Cells, Animal And Human, Cultured

Hematology

Cultured Animal and Human Cells are living cell preparations derived from animal or human sources, maintained in culture for use as laboratory reagents in biological assays, virus propagation, cytotoxicity testing, and other in vitro diagnostic and research laboratory applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIR, regulated under 21 CFR 864.2280, within the Hematology medical specialty.

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510(k)s

170

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KIR
Device Class: FDA class 1
Regulation Number: 864.2280
Medical Specialty: Hematology
Review Panel: PA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 170 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K973214	FRESH CELLS HFF	Sep 25, 1997	Substantially Equivalent	Diagnostic Hybrids, Inc.
K973213	FRESH CELLS LLC-MK2	Sep 25, 1997	Substantially Equivalent	Diagnostic Hybrids, Inc.
K973212	FRESH CELLS WI-38	Sep 25, 1997	Substantially Equivalent	Diagnostic Hybrids, Inc.
K973211	FRESH CELLS MV1LU	Sep 25, 1997	Substantially Equivalent	Diagnostic Hybrids, Inc.
K973210	FRESH CELLS NCI H292	Sep 25, 1997	Substantially Equivalent	Diagnostic Hybrids, Inc.
K973209	FRESH CELLS VERO	Sep 25, 1997	Substantially Equivalent	Diagnostic Hybrids, Inc.
K971508	RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE	Sep 17, 1997	Substantially Equivalent	Bio-Whittaker, Inc., A Cambrex Co.
K972414	FRESHCELLS	Aug 29, 1997	Substantially Equivalent	Diagnostic Hybrids, Inc.
K965047	MINK LUNG CELL CULTURE	Feb 04, 1997	Substantially Equivalent	Neogenex
K962782	FRESHFROZEN CELLS, HEP-2	Aug 29, 1996	Substantially Equivalent	Diagnostic Hybrids, Inc.
K962780	FRESHCELLS, HEP-2	Aug 29, 1996	Substantially Equivalent	Diagnostic Hybrids, Inc.
K962311	FRESHFROZENCELLS	Aug 29, 1996	Substantially Equivalent	Diagnostic Hybrids, Inc.
K962306	FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES	Aug 29, 1996	Substantially Equivalent	Diagnostic Hybrids, Inc.
K955608	MCCOY CELL CULTURES	Jul 08, 1996	Substantially Equivalent	Vai Diagnostics, Inc.
K960909	H292 CELL CULTURE	May 30, 1996	Substantially Equivalent	Neogenex
K951461	NCI-H292 CELL CULTURE	May 22, 1996	Substantially Equivalent	Viromed Laboratories, Inc.
K951440	LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE	May 22, 1996	Substantially Equivalent	Viromed Laboratories, Inc.
K955921	A549 CELL CULTURE	Feb 16, 1996	Substantially Equivalent	Viratest Intl., Inc.
K952727	MRC-5 CELL CULTURE VIAL	Nov 20, 1995	Substantially Equivalent	Viratest Intl., Inc.
K942820	H292	May 05, 1995	Substantially Equivalent	Bartels, Inc.
K943891	RD CULTURE CELL	Nov 28, 1994	Substantially Equivalent	Neogenex
K943890	WI38 CELL CULTURE	Nov 28, 1994	Substantially Equivalent	Neogenex
K943889	VERO CELL CULTURE	Nov 28, 1994	Substantially Equivalent	Neogenex
K943888	MDCK CELL CULTURE	Nov 28, 1994	Substantially Equivalent	Neogenex
K943887	HUMAN NEWBORN FORESKIN CELL CULTURE	Nov 28, 1994	Substantially Equivalent	Neogenex
K943886	BGM CELL CULTURE	Nov 28, 1994	Substantially Equivalent	Neogenex
K943885	PRIMARY RABBIT KIDNEY CELL CULTURE	Nov 28, 1994	Substantially Equivalent	Neogenex
K943884	PRIMARY MONKEY KIDNEY CELL CULTURE	Nov 28, 1994	Substantially Equivalent	Neogenex
K936271	FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE	Aug 26, 1994	Substantially Equivalent	Diagnostic Hybrids, Inc.
K940502	FRESH FROZEN CELLS	Jun 16, 1994	Substantially Equivalent	Diagnostic Hybrids, Inc.
K933927	HEP-2 CULTURE CELL	Mar 31, 1994	Substantially Equivalent	Neogenex
K933926	LLCMK2 CULTURE CELLS	Mar 29, 1994	Substantially Equivalent	Neogenex
K933925	MRC-5 CULTURE CELL	Mar 29, 1994	Substantially Equivalent	Neogenex
K933924	MCCOY CULTURE CELL	Mar 29, 1994	Substantially Equivalent	Neogenex
K933923	A549 CULTURE CELL	Mar 29, 1994	Substantially Equivalent	Neogenex
K936172	RHESUS MONKEY KIDNEY CELLS (LLC-MK2)	Feb 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K936171	TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY	Feb 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K936169	RHESUS MONKEY KIDNEY CELLS	Feb 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934973	HELA-229/HELA CELLS	Jan 28, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934934	RABBIT KIDNEY CELLS - R.K.C.	Jan 28, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K935766	PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS	Jan 24, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K935339	HELA HELA EPITHELOID CARCINOMA	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K935338	LUNG CACINOMA, HUMAN CELLS	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K935337	RHABDOMYOSARCOMA CELLS	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K935336	CYNOMOLOGUS MONKEY KIDNEY CELLS	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934246	LUNG DIPLOID HUMAN CELLS-WI-38	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934245	HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934244	HUMAN LUNG DIPLOID CELLS-MRC-5	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934243	HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934242	BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934241	MCCOY CULTURE CELLS-MCCOY	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934240	KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K934239	KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1	Jan 03, 1994	Substantially Equivalent	Advanced Clinical Diagnostics
K930398	16 X 125 MM TEST TUBE, CATALOG #01-441	Mar 24, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930397	16 X 125 MM TEST TUBE, CATALOG	Mar 24, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930396	16 X 125 MM TEST TUBE, CATALOG #01-291	Mar 24, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930395	ONE DRAM SHELL VIAL, CATALOG #02-461	Mar 24, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930394	25 CM2, 75 CM2, A50 CM2 FLASK, CATALOG #03-211	Mar 24, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930393	ONE DRAM SHELL VIAL, CATALOG #02-261	Mar 24, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930392	16 X 125 MM TEST TUBE, CATALOG #01-111	Mar 24, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930391	25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-261	Mar 24, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930390	25 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-291	Mar 24, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930389	ONE DRAM SHELL VIAL, CATALOG #02-291	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930388	16 X 125 MM TEST TUBE, CATALOG #01-241	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930387	ONE DRAM SHELL VIAL, CATALOG #02-401	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930386	16 X 125 MM TEST TUBE, CATALOG #01-401	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930385	16 X 125 MM TEST TUBE, CATALOG #01-421	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930384	25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-401	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930383	25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-421	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930382	ONE DRAMSHELL VIAL, CATALOG #02-421	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930381	ONE DRAM SHELL VIAL, CATALOG #02-441	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930380	16 X 125 MM TEST TUBE, CATALOG #01-261	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930379	ONE DRAM SHELL VIAL, CATALOG #02-281	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930378	25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930377	25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-461	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930376	ONE DRAM SHELL VIAL, CATALOG #02-211	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930375	16 X 125 MM TEST TUBE, CATALOG #01-211	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930374	25 CM2, 75 CM2, 150 CM2, FLASK, CATALOG #03-111	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930373	ONE DRAM SHELL VIAL, CATALOG #02-111	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930372	16 X 125 MM TEST TUBE, CATALOG #01-311	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930371	16 X 125 MM TEST TUBE, CATALOG #01-321	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930370	ONE DRAM SHELL VIALS, CATALOG #02-311	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930369	25CM, 75CM, 150CM, FLASK, CATALOG #03-311	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930368	ONE DRAM SHELL VIAL, CATALOG #02-321	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930367	25CM2. 75CM2, 150 CM, FLASK, CATALOG #03-321	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930366	16 X 25 MM TEST TUBE, CATALOG #01-461	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930365	25CM2, 75CM2, 150CM2 FLASK, CATALOG #03-241	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930364	ONE DRAM SHELL VIAL, CATALOG # 02-241	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K930325	CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS	Mar 23, 1993	Substantially Equivalent	Proteins Intl., Inc.
K924625	CYTOQUANT HLNFS CELLS, CATLOG #03-151	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924624	CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924623	CYTOQUANT A-549 CELLS, CATALOG #03-201	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924622	CYTOQUANT A-549 CELLS, CATALOG #02-201	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924621	CYTOQUANT MRC-5 CELLS, CATALOG #02-101	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924620	CYTOQUANT MRC-5 CELLS, CATALOG #03-101	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924619	CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-101	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924618	CYTOQUANT HEP-2 CELLS 25CM/75CM/175CM FLASK#03-251	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924617	CYTOQUANT HEP-2 CELLS 16 X 125 MM TUBE, #01-251	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924616	CYTOQUANT HEP-2 CELLS, CATALOG #02-251	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924615	CYTOQUANT H292 CELLS 25CM2/75CM2/175CM2 FLASK	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924614	CYTOQUANT H292 HUMAN PULM MUCOEPIDER CARCIN CELLS	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924613	CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-301	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924612	CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-301	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K924595	CYTOQUANT HNFS CELLS	Dec 07, 1992	Substantially Equivalent	Proteins Intl., Inc.
K902726	BARTELS EXTRACELLULAR MATRIX	Sep 24, 1990	Substantially Equivalent	Baxter Healthcare Corp
K896846	MADIN-DARBY CANINE KIDNEY CULTURE CELLS	Feb 01, 1990	Substantially Equivalent	Baxter Healthcare Corp
K871613	BUFFALO GREEN MONKEY KIDNEY CELLS	May 13, 1987	Substantially Equivalent	Viromed Laboratories, Inc.
K871033	RABBIT KIDNEY CULTURE CELLS (FIRST PASS)	Mar 31, 1987	Substantially Equivalent	Microscan Div. Baxter Healthcare Corp.
K864776	A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS	Dec 31, 1986	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K862555	HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)	Jul 10, 1986	Substantially Equivalent	Viromed Laboratories, Inc.
K861585	ULTRACLONE 01-2300 CELL LINE	May 13, 1986	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K861569	ULTRACLONE 01-700 CELL LINE	May 05, 1986	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K861373	HUMAN LUNG CARCINOMA CELLS (A549)	Apr 18, 1986	Substantially Equivalent	Viromed Laboratories, Inc.
K860293	CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS	Feb 05, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K860292	CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000	Feb 05, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K853203	ULTRACLONE ECL-01-2200 CELL LINE	Aug 12, 1985	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K852396	HEK	Jul 12, 1985	Substantially Equivalent	Viromed Laboratories, Inc.
K852395	MINK LUNG	Jul 12, 1985	Substantially Equivalent	Viromed Laboratories, Inc.
K852394	MDCK	Jul 12, 1985	Substantially Equivalent	Viromed Laboratories, Inc.
K852206	HEP-2 GENCELLS	Jun 04, 1985	Substantially Equivalent	Genus Diagnostics
K852205	RMK GENCELLS CULTURE SYSTEM	Jun 04, 1985	Substantially Equivalent	Genus Diagnostics
K852204	MCCOY GENCELLS	Jun 04, 1985	Substantially Equivalent	Genus Diagnostics
K851928	HEK GENCELLS	May 20, 1985	Substantially Equivalent	Genus Diagnostics
K851927	VERO GENCELLS	May 20, 1985	Substantially Equivalent	Genus Diagnostics
K851563	RK GENCELLS	May 10, 1985	Substantially Equivalent	Genus Diagnostics
K851562	MRC-5 GENCELLS	May 10, 1985	Substantially Equivalent	Genus Diagnostics
K851561	WI-38 GENCELLS	May 10, 1985	Substantially Equivalent	Genus Diagnostics
K851545	ULTRACLONE ECL-01-800 CELL LINE	May 10, 1985	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K840366	CELL-MATICS HERPES SIMPLEX VIRUS DETECT	Jan 08, 1985	Substantially Equivalent	Difco Laboratories, Inc.
K843579	ULTRACLONE ECL-01-1100	Oct 31, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K843578	ULTRACLONE ECL-01-2100 CELL LINE	Oct 31, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K843577	ULTRAXLONE ECL-01-1000 CELL LINE	Oct 31, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K843252	AFRICAN GREEN SV 5/SV 40	Sep 06, 1984	Substantially Equivalent	Viromed Laboratories, Inc.
K843251	RD CELLS	Sep 06, 1984	Substantially Equivalent	Viromed Laboratories, Inc.
K843250	BHK-21	Sep 06, 1984	Substantially Equivalent	Viromed Laboratories, Inc.
K842584	HEK	Jul 27, 1984	Substantially Equivalent	Viromed Laboratories, Inc.
K842583	SIRC	Jul 27, 1984	Substantially Equivalent	Viromed Laboratories, Inc.
K841998	IMR-90-DIPLOID-HUMAN FETAL LUNG CELL	Jun 27, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K842000	PRIMARY RABBITT KIDNEY CELL CULTURE	Jun 22, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K841999	BGM CELL CULTURE AFRICAN GREEN MONKEY	Jun 22, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K841806	WI-38	Jun 07, 1984	Substantially Equivalent	Viromed Laboratories, Inc.
K841346	ULTRACLONE ECL-01-200 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841345	ULTRACLONE ECL-01-500 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841344	ULTRACLONE ECL-01-300 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841343	ULTRACLONE ECL-01-100 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841342	ULTRACLONE ECL-01-400 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841341	ULTRACLONE ECL-01-1000 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841340	ULTRACLONE ECL-01-900 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841339	ULTRA CLONE ECL-01-700 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841338	ULTRACLONE ECL-01-600 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841337	ULTRACLONE ECL-01-800 CELL LINE	May 11, 1984	Substantially Equivalent	Earl-Clay Laboratories, Inc.
K841666	RABBIT KIDNEY CELLS	May 07, 1984	Substantially Equivalent	Viromed Laboratories, Inc.
K841665	RHESUS SV5/SV40	May 07, 1984	Substantially Equivalent	Viromed Laboratories, Inc.
K834126	MRC-5 CELLS	Mar 22, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K834124	VERO CELLS	Mar 22, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K834123	WI-38 HUMAN LUNG CELLS	Mar 22, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K834120	LLC-MK2-RHESUS MONKEY KIDNEY CELLS	Mar 22, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K834119	MCCOY CELLS	Mar 22, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K834117	HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN	Mar 22, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K833360	HEP-2 CELLS	Nov 03, 1983	Substantially Equivalent	Biocon, Inc.
K833359	WI-38 CELLS	Nov 03, 1983	Substantially Equivalent	Biocon, Inc.
K833358	MRC-5 CELLS	Nov 03, 1983	Substantially Equivalent	Biocon, Inc.
K832947	ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO	Sep 29, 1983	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K831684	CYNOMOLGUS MONKEY KIDNEY CELLS SV5	Jul 06, 1983	Substantially Equivalent	Viromed Laboratories, Inc.
K831683	SF CELLS	Jul 06, 1983	Substantially Equivalent	Viromed Laboratories, Inc.
K831682	MCCOY CELLS	Jul 06, 1983	Substantially Equivalent	Viromed Laboratories, Inc.
K831681	HEP-2 CELLS	Jul 06, 1983	Substantially Equivalent	Viromed Laboratories, Inc.
K831680	VERO CELLS	Jul 06, 1983	Substantially Equivalent	Viromed Laboratories, Inc.
K831679	MRC-5 CELLS	Jul 06, 1983	Substantially Equivalent	Viromed Laboratories, Inc.
K780869	CELL CULTURE LINES	Aug 14, 1978	Substantially Equivalent	Bioassay Systems Research Corp.