Product Code: JSF FDA class 1 21 CFR 866.2320

Culture Media, Single Biochemical Test

Microbiology

The Culture Media, Single Biochemical Test is a microbiology diagnostic medium designed to perform a single defined biochemical test reaction that detects a specific metabolic property of a microorganism, used to confirm the identity of bacterial isolates as part of routine clinical microbiology identification procedures. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JSF and is regulated under 21 CFR 866.2320, within the Microbiology medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: JSF
Device Class: FDA class 1
Regulation Number: 866.2320
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 87 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K880946	NUTRIENT GELATIN - PRODUCT NUMBER T2860	Apr 01, 1988	Substantially Equivalent	LAKEWOOD BIOCHEMICAL CO., INC.
K880126	LAURYL TRYPTOSE BROTH	Mar 31, 1988	Substantially Equivalent	HARDY MEDIA
K880120	MOELLERS DECARBOXYLASE, LYSINE	Mar 31, 1988	Substantially Equivalent	HARDY MEDIA
K880119	MOELLERS DECARBOXYLASE, ONITHINE	Mar 31, 1988	Substantially Equivalent	HARDY MEDIA
K880139	ONPG TEST REAGENT	Mar 30, 1988	Substantially Equivalent	HARDY MEDIA
K880135	NITRATE BROTH	Mar 30, 1988	Substantially Equivalent	HARDY MEDIA
K880129	BRILLIANT GREEN BILE BROTH	Mar 30, 1988	Substantially Equivalent	HARDY MEDIA
K880118	MOELLOERS DECARBOXYLASE, ARGININE	Mar 30, 1988	Substantially Equivalent	HARDY MEDIA
K880113	CYSTINE TRYPTIC MEDIUM W/LACTOSE	Mar 30, 1988	Substantially Equivalent	HARDY MEDIA
K880112	CYSTINE TRYPTIC MEDIUM W/ MALTOSE	Mar 30, 1988	Substantially Equivalent	HARDY MEDIA
K880111	CYSTINE TRYPTIC MEDIUM W/SUCROSE	Mar 30, 1988	Substantially Equivalent	HARDY MEDIA
K880110	CYSTINE TRYPTIC MEDIUM W/DEXTROSE	Mar 30, 1988	Substantially Equivalent	HARDY MEDIA
K880106	ACETAMIDE AGAR SLANT	Mar 30, 1988	Substantially Equivalent	HARDY MEDIA
K880115	NUTRIENT GELATIN	Mar 08, 1988	Substantially Equivalent	HARDY MEDIA
K874175	BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC	Dec 04, 1987	Substantially Equivalent	OTISVILLE BIOPHARM, INC.
K874174	BIOTIS (TM) STARCH HYDROLYSIS WITH BCP	Dec 04, 1987	Substantially Equivalent	OTISVILLE BIOPHARM, INC.
K873828	CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990	Oct 06, 1987	Substantially Equivalent	LAKEWOOD BIOCHEMICAL CO., INC.
K872691	IAFP UREA AGAR SLANT	Aug 11, 1987	Substantially Equivalent	I.A.F. PRODUCTION, INC.
K870641	TRYPTONE BROTH, 2%	Apr 14, 1987	Substantially Equivalent	HARDY MEDIA
K864256	TRYPTONE WATER (1%)	Mar 31, 1987	Substantially Equivalent	MDS LABORATORIES, INC.
K864241	DNASE AGAR	Mar 31, 1987	Substantially Equivalent	MDS LABORATORIES, INC.
K862398	BIOTIS DECARBOXYLASE MEDIA, ORNITHINE	Jul 03, 1986	Substantially Equivalent	OTISVILLE BIOTECH, INC.
K862397	BIOTIS DECARBOXYLASE MEDIA, LYSINE	Jul 03, 1986	Substantially Equivalent	OTISVILLE BIOTECH, INC.
K862396	BIOTIS DECARBOXYLASE MEDIA, ARGININE	Jul 03, 1986	Substantially Equivalent	OTISVILLE BIOTECH, INC.
K862392	BIOTIS MOTILITY TEST MEDIUM	Jul 03, 1986	Substantially Equivalent	OTISVILLE BIOTECH, INC.
K850194	CAFFEIC ACID DISK	Apr 22, 1985	Substantially Equivalent	REMEL CO.
K850550	SIMMONS CITRATE AGAR	Mar 11, 1985	Substantially Equivalent	HARDY MEDIA
K850545	ACETATE DIFFERENTIAL AGAR	Mar 11, 1985	Substantially Equivalent	HARDY MEDIA
K844546	CYSTINE TRYPTIC AGAR W/SUCROSE	Jan 16, 1985	Substantially Equivalent	BIO MERIEUX, INC.
K844545	CYSTINE TRYPTIC AGAR W/MANNITOL	Jan 16, 1985	Substantially Equivalent	BIO MERIEUX, INC.
K844544	CYSTINE TRYPTIC AGAR W/MALTOSE	Jan 16, 1985	Substantially Equivalent	BIO MERIEUX, INC.
K844543	CYSTINE TRYPTIC AGAR W/LACTOSE	Jan 16, 1985	Substantially Equivalent	BIO MERIEUX, INC.
K844542	CYSTINE TRYPTIC AGAR W/DEXTROSE	Jan 16, 1985	Substantially Equivalent	BIO MERIEUX, INC.
K844540	CYSTINE TRYPTIC AGAR W/FRUCTOSE	Jan 07, 1985	Substantially Equivalent	BIO MERIEUX, INC.
K844539	PHENOL RED BROTH W/CARBOHYDRATES	Jan 07, 1985	Substantially Equivalent	BIO MERIEUX, INC.
K843364	DIFFERENTIATION DISKS BILE ESCULIN	Sep 07, 1984	Substantially Equivalent	DIFCO LABORATORIES, INC.
K842871	HIPPURATE TEST REAGENT	Aug 07, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K842869	DECARBOXYLASE TEST REAGENT	Aug 07, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K842872	INDOLE REAGENT	Aug 03, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K842870	VOGES-PROSKAUER REAGENT A	Aug 03, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K842868	HIPPURATE TEST DISKS	Aug 03, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K842867	VOGES-PROSKAUER REAGENT B	Aug 03, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K842855	CHRISTENSEN'S UREA AGAR	Aug 03, 1984	Substantially Equivalent	ANAROBE SYSTEMS
K842853	LYSINE IRON AGAR	Aug 03, 1984	Substantially Equivalent	ANAROBE SYSTEMS
K842600	STREP-A-CHEK	Jul 11, 1984	Substantially Equivalent	E-Y LABORATORIES, INC.
K842299	ZINC DUST SUSPENSION	Jun 26, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K842298	OXIDASE TEST STRIPS-OXIDASESURE	Jun 25, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K842300	ONPG DISKS	Jun 22, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K842297	ARGINIE BROTH	Jun 22, 1984	Substantially Equivalent	REMEL CO.
K842291	SPOT TEST CATALASE TEST	Jun 22, 1984	Substantially Equivalent	DIFCO LABORATORIES, INC.
K842290	SPOT TEST NINHYDRIN REAGENTS	Jun 22, 1984	Substantially Equivalent	DIFCO LABORATORIES, INC.
K842098	RIM H2S	Jun 19, 1984	Substantially Equivalent	AUSTIN BIOLOGICAL LABORATORIES
K842097	RIM SPOT INDOLE	Jun 07, 1984	Substantially Equivalent	AUSTIN BIOLOGICAL LABORATORIES
K842072	L-ALANINE-4-NITROANILIDE	Jun 07, 1984	Substantially Equivalent	IRVINE DIAGNOSTIC SERVICES
K841659	DRIGALSKI LITMUS LACTOSE AGAR	Jun 07, 1984	Substantially Equivalent	OXOID U.S.A., INC.
K841389	RIM-DNASE KIT	May 02, 1984	Substantially Equivalent	AUSTIN BIOLOGICAL LABORATORIES
K840685	PORPHYRIN TEST AGAR	Apr 17, 1984	Substantially Equivalent	REMEL CO.
K841212	SINGLE BIOCHEMICAL TEST	Apr 04, 1984	Substantially Equivalent	SMITH RIVER BIOLOGICALS
K834327	CIN AGAR	Jan 13, 1984	Substantially Equivalent	HARDY MEDIA
K830397	PEM-C	Apr 12, 1983	Substantially Equivalent	HEALTH DEVELOPMENT CORP.
K823001	PEPTONE IRON AGAR	Nov 16, 1982	Substantially Equivalent	GRANITE DIAGNOSTICS, INC.
K823000	MACATE BROTH	Nov 16, 1982	Substantially Equivalent	GRANITE DIAGNOSTICS, INC.
K822999	DNASE TEST AGAR W/TOLUIDINE BLUE	Nov 16, 1982	Substantially Equivalent	GRANITE DIAGNOSTICS, INC.
K822996	JORDANS TARTRATE AGAR	Nov 16, 1982	Substantially Equivalent	GRANITE DIAGNOSTICS, INC.
K822995	ANDRADES FERMENTATION MEDIA	Nov 16, 1982	Substantially Equivalent	GRANITE DIAGNOSTICS, INC.
K822694	YEAST ASSIMILATION BROTH	Sep 30, 1982	Substantially Equivalent	GRANITE DIAGNOSTICS, INC.
K821845	EGG YOLK AGAR (PLATE)	Jul 08, 1982	Substantially Equivalent	GRANITE DIAGNOSTICS, INC.
K821594	UREA AGAR SLANT	Jul 08, 1982	Substantially Equivalent	HARDY MEDIA
K821593	BILE ESCULIN AZIDE BROTH	Jul 08, 1982	Substantially Equivalent	HARDY MEDIA
K821606	BILE ESCULIN AGAR	Jul 06, 1982	Substantially Equivalent	HARDY MEDIA
K820839	CULTURE MEDIA, SINGLE BIOCHEM. TEST	Apr 16, 1982	Substantially Equivalent	BLUE RIDGE MEDIA CO.
K820809	#2008 SIMMONS CITRATE	Apr 08, 1982	Substantially Equivalent	BIOMEDICA, INC.
K820149	PYR BROTH	Feb 05, 1982	Substantially Equivalent	CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
K812470	HIPP MICROTUBE	Sep 14, 1981	Substantially Equivalent	CARR MICROBIOLOGICALS
K812469	RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB	Sep 14, 1981	Substantially Equivalent	CARR MICROBIOLOGICALS
K812468	PYRR MICROTUBE	Sep 14, 1981	Substantially Equivalent	CARR MICROBIOLOGICALS
K812465	PHOS MICROTUBES	Sep 14, 1981	Substantially Equivalent	CARR MICROBIOLOGICALS
K800287	CEPH LACTAM DISK	Mar 19, 1980	Substantially Equivalent	REMEL CO.
K791945	NITRATE BROTH	Oct 30, 1979	Substantially Equivalent	ISLE MEDIA AND STERILE PRODUCTS, INC.
K791476	.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)	Sep 04, 1979	Substantially Equivalent	ISLE MEDIA AND STERILE PRODUCTS, INC.
K791474	SIMMONS CITRATE AGAR	Sep 04, 1979	Substantially Equivalent	ISLE MEDIA AND STERILE PRODUCTS, INC.
K790626	LOMBARD-DOWELL GLUCOSE AGAR	Apr 23, 1979	Substantially Equivalent	ANAEROBE SYSTEMS
K790231	DECARBOXYLASE, BUFFERED LYSINE	Feb 21, 1979	Substantially Equivalent	LOS ANGELES BIOLOGICAL PRODUCTS
K781506	MIC-BIO-PLATE	Oct 17, 1978	Substantially Equivalent	PASCO LABORATORIES, INC.
K781369	MICRODILUTION ANAEROBE ID. PANEL	Oct 03, 1978	Substantially Equivalent	CNR LABS
K780907	MIC-2000	Jun 22, 1978	Substantially Equivalent	GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K780533	PRE-REDUCED MEDIA	Apr 18, 1978	Substantially Equivalent	GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.

FEI Numbers

This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

1000354384: 13 registrations

1111096: 41 registrations

1119779: 302 registrations

1210083: 13 registrations

1924669: 195 registrations

2022807: 109 registrations

3002681225: 19 registrations

3003750284: 140 registrations

3005182157: 15 registrations

3005182159: 19 registrations

3009547954: 39 registrations

3015715780: 15 registrations

3016837106: 21 registrations

3017056269: 6 registrations

3020831613: 10 registrations