Product Code: JSH FDA class 1 21 CFR 866.2320

Culture Media, Non-Selective And Differential

Microbiology

The Culture Media, Non-Selective and Differential is a microbiology diagnostic medium that supports the growth of a wide variety of microorganisms but contains indicators or reagents that produce visible differences in colony morphology or color based on the organisms' metabolic properties, enabling differentiation of colony types without inhibiting growth. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JSH and is regulated under 21 CFR 866.2320, within the Microbiology medical specialty.

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510(k)s

146

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JSH
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 146 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K881560	UREA BROTH	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881559	UREA AGAR BASE	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881553	RUSSELL DOUBLE SUGAR AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881551	PHENOL RED BROTH BASE	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881540	FLO AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881486	DNASE TEST AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K880121	MOELLERS DECARBOXYLASE, BASE	Mar 31, 1988	Substantially Equivalent	Hardy Media
K880117	OF MEDIUM BASE	Mar 30, 1988	Substantially Equivalent	Hardy Media
K873270	ACTINOMYCETE DIFFERENTIAL MEDIA	Nov 04, 1987	Substantially Equivalent	Central Media
K873263	MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA	Oct 28, 1987	Substantially Equivalent	Central Media
K873411	SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084	Oct 06, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873704	MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053	Oct 02, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873703	LYSINE IRON AGAR (LIA) PRODUCT #T3046	Oct 02, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K872670	IAFP MAC CONKEY AGAR	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872020	MUCATE AGAR, SLANTS AND MUCATE BROTH	Jun 02, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K871855	SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM	May 26, 1987	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K871701	ARYLSULFATASE BROTH	May 20, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K870651	BIGGY AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870636	HEMOPHILUS ID QUAD PLATE	Apr 14, 1987	Substantially Equivalent	Hardy Media
K871095	CLED AGAR	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K864239	CLED AGAR WITH ANDRADES INDICATOR	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K864454	THERMOSTABLE NUCLEASE TEST AGAR	Nov 28, 1986	Substantially Equivalent	Dimed, Intl.
K864205	THERMONUCLEASE AGAR W/TOLUIDINE BLUE	Nov 24, 1986	Substantially Equivalent	Remel Co.
K864100	TRYCOPHYTON AGARS	Oct 31, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863600	MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM	Sep 30, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863599	STARCH AGAR W/BROM CRESOL PURPLE	Sep 30, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863573	BIRD SEED AGAR	Sep 30, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863572	XANTHINE/TYROSINE/CASEIN AGAR	Sep 30, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863523	TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR	Sep 19, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K862395	BIOTIS DECARBOXYLASE MEDIA, BASE	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K862387	BIOTIS HAEMOPHILUS IDENTIFICATION QUAD	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860750	PSEUDOMONAS AGAR P (MEDIUM A)	Mar 10, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K853619	APL TRIPLE SUGAR IRON AGAR	Sep 16, 1985	Substantially Equivalent	Apl Medical Supplies
K853618	APL SIM MEDIUM	Sep 16, 1985	Substantially Equivalent	Apl Medical Supplies
K853610	APL MOTILITY INDOLE ORNITHINE AGAR	Sep 16, 1985	Substantially Equivalent	Apl Medical Supplies
K853616	APL CHLAMYDOSPORE AGAR	Sep 06, 1985	Substantially Equivalent	Apl Medical Supplies
K853615	APL BILE ESCULIN/AZIDE AGAR	Sep 06, 1985	Substantially Equivalent	Apl Medical Supplies
K853614	APL FLUID THIOGLYCOLLATE MEDIUM	Sep 06, 1985	Substantially Equivalent	Apl Medical Supplies
K853613	APL GN BROTH	Sep 06, 1985	Substantially Equivalent	Apl Medical Supplies
K853612	APL DNASE TEST AGAR	Sep 06, 1985	Substantially Equivalent	Apl Medical Supplies
K853336	DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR	Aug 29, 1985	Substantially Equivalent	Hardy Media
K852578	CLED AGAR	Jul 12, 1985	Substantially Equivalent	American Laboratory Supply, Inc.
K852064	DRI-FORM PSEUDOMONAS AGAR F	Jun 04, 1985	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K851597	TRIPLE SUGAR IRON AGAR	May 13, 1985	Substantially Equivalent	Preferred Micro-Media
K851596	SIM MEDIUM	May 13, 1985	Substantially Equivalent	Preferred Micro-Media
K851595	SIMMONS CITRATE AGAR	May 13, 1985	Substantially Equivalent	Preferred Micro-Media
K851576	BIGGY AGAR NICKERSONS MEDIUM	May 09, 1985	Substantially Equivalent	Preferred Micro-Media
K851602	UREA AGAR	May 08, 1985	Substantially Equivalent	Preferred Micro-Media
K851344	OXIDATIVE FORMENTIVE MEDIUM	Apr 22, 1985	Substantially Equivalent	Micro Media Laboratories
K851346	PHENYLALANINE AGAR	Apr 19, 1985	Substantially Equivalent	Micro Media Laboratories
K851345	PURPLE BROTH	Apr 19, 1985	Substantially Equivalent	Micro Media Laboratories
K851343	BROM CRESOL PURPLE STARCH	Apr 19, 1985	Substantially Equivalent	Micro Media Laboratories
K850721	KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E	Mar 22, 1985	Substantially Equivalent	Rapid City Regional Hospital, Inc.
K850719	DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR	Mar 22, 1985	Substantially Equivalent	Rapid City Regional Hospital, Inc.
K850844	V AGAR	Mar 20, 1985	Substantially Equivalent	Micro Media Laboratories
K850718	CORN MEAL AGAR	Mar 20, 1985	Substantially Equivalent	Rapid City Regional Hospital, Inc.
K844548	UREA AGAR	Jan 16, 1985	Substantially Equivalent	bioMerieux, Inc.
K844532	SIMMONS CITRATE AGAR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844531	TRIPLE SUGAR IRON	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844522	SF BROTH	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844521	SIM MEDIUM	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844520	KLIGER IRON AGAR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844519	HAEMOPHILUS I.D. QUAD	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844516	STARCH HYDROLYSIS AGAR W/INDICATOR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844514	DTM AGAR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844513	V AGAR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K843771	BIOTIS SEVEN H 11 AGAR	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K843769	BIOTIS LOWENSTEIN-JENSEN MEDIA	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K842850	TRIPLE SUGAR IRON	Aug 17, 1984	Substantially Equivalent	Anarobe Systems
K842851	ORNITHINE INDOLE MOTILITY	Aug 07, 1984	Substantially Equivalent	Anarobe Systems
K841843	DIFFERENTIAL CULTURE MED. LEVINE EMB	May 31, 1984	Substantially Equivalent	Microline Scientific
K841206	NON-SELECTIVE & DIFFERENTIAL	Apr 17, 1984	Substantially Equivalent	Smith River Biologicals
K840073	ESCULIN AGAR PLATE	Feb 03, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K840071	DNASE AGAR W/TOLUDINE BLUE PLATE	Feb 03, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K840070	EGG YOLK AGAR PLATE	Jan 30, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K840068	BILE ESCULIN AGAR PLATE	Jan 30, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834509	ACETAMIDE AGAR SLANTS	Jan 27, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K834205	MIDDLEBROOK & COHN 7H10 AGAR BASE	Jan 03, 1984	Substantially Equivalent	Acumedia Manufacturers, Inc.
K834204	MIDDLEBROOK & COHN 7H11 AGAR BASE	Jan 03, 1984	Substantially Equivalent	Acumedia Manufacturers, Inc.
K834009	SIMMONS CITRATE AGAR	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K833291	JH PEPTONE AGAR	Nov 28, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833216	MOTILITY TEST MEDIUM	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833213	KLIGLER IRON AGAR	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833208	MR-VP BROTH	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833206	TECH AGAR	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833202	MOELLER DECARBOXYLASE BROTH	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833201	SIMMONS CITRATE AGAR	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K832532	AGAR PLATE XLD	Sep 29, 1983	Substantially Equivalent	Otisville Biotech, Inc.
K832616	MACCONKEY AGAR MEDIA	Sep 12, 1983	Substantially Equivalent	Carroll Biological Corp.
K832574	BTB LACTOSE AGAR	Sep 12, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K832573	C.L.E.D. MEDIUM	Sep 12, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K831827	EGG YOLK AGAR	Jul 26, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K830073	LEVINE EMB AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830020	ACETAMIDE AGAR	Feb 07, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K823311	COLUMBIA V AGAR W/5% HUMAN BLOOD	Dec 15, 1982	Substantially Equivalent	Troy Biologicals, Inc.
K823091	H BROTH	Nov 05, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K823071	RICE EXTRACT AGAR	Nov 05, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K823070	ACETAMIDE AGAR SLANT	Nov 05, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K822702	V AGAR	Sep 30, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K822377	HAEMOPHILUS ID PLATE	Aug 25, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K821659	RESPIRACULT-STREP DEEP BED CULTURE PAD	Aug 05, 1982	Substantially Equivalent	Orion Diagnostica, Inc.
K821595	MOTILITY TEST MEDIUM	Jul 08, 1982	Substantially Equivalent	Hardy Media
K821609	VAGAR	Jul 06, 1982	Substantially Equivalent	Hardy Media
K821425	COLUMBIA BLOOD AGAR W/5% SHEEP BLOOD	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821424	TRYPTIC SOY AGAR W/5% SHEEP BLOOD	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821418	TRYPTOSE BLOOD AGAR W/5% SHEEP BLOOD	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821417	TRYPTIC SOY AGAR W/10% SHEEP BLOOD	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821302	#50003 QUAD DIAGNOSTIC SYSTEM	Jun 01, 1982	Substantially Equivalent	Biomedia, Inc.
K811852	REDUCT-ASE TUBES	Jul 16, 1981	Substantially Equivalent	Microchemical Specialities, Co.
K811597	UREA AGAR SLANT	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811335	THIOGLYCOLLATE GELATIN MEDIUM	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811330	SIM MEDIUM	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811130	LACTOSE BROTH	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811044	TRIPLE SUGAR IRON AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K802995	TRYPTICASE SOY AGAR W/5% SHEEP BLD. CELL	Dec 22, 1980	Substantially Equivalent	Sacks Farms Biological Products
K802994	TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL	Dec 22, 1980	Substantially Equivalent	Sacks Farms Biological Products
K801817	MICROBIOLOGY CULTURE MEDIA, C.L.E.D.	Aug 27, 1980	Substantially Equivalent	Radiation Technology, Inc.
K801847	TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA	Aug 13, 1980	Substantially Equivalent	Radiation Technology, Inc.
K800978	XYLOSE LYSINE DESOXYCHOLATE AGAR	May 28, 1980	Substantially Equivalent	Quality Assurance Laboratory, Inc.
K800984	EOSIN METHYLENE BLUE AGAR, LEVINE	May 23, 1980	Substantially Equivalent	Quality Assurance Laboratory, Inc.
K800982	SALMONELLA SHIGELLA AGAR	May 23, 1980	Substantially Equivalent	Quality Assurance Laboratory, Inc.
K800818	CHLAMYDOSPORE AGAR	Apr 24, 1980	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792542	VOGEL-JOHNSON AGAR	Dec 31, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792421	DECARBOXYLASE BROTH BASE WITH OR WITH-	Dec 31, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792544	LYSINE IRON AGAR	Dec 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792288	TRYPTONE BROTH (TRYPTOPHANE BROTH)	Dec 19, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792286	MR-VP MEDIUM	Dec 19, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791946	OF BASAL MEDIUM	Oct 30, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791944	NITRATE AGAR	Oct 30, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791941	PHENOL RED BROTH	Oct 30, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791939	PHENOL RED AGAR	Oct 30, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791817	MIO MEDIUM (MOTILITY INDOLE ORNITHINE)	Oct 01, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791814	BILE ESCULIN AGAR	Oct 01, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791813	DNASE TEST AGAR W/METHYL GREEN	Oct 01, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791671	DNASE TEST AGAR	Oct 01, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791594	CYSTINE TRYPTIC AGAR	Sep 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791591	MOTILITY TEST MEDIUM	Sep 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791590	PHENYLALANINE AGAR	Sep 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791556	MACCONKEY AGAR (PLATE)	Sep 17, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K790627	LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID	May 01, 1979	Substantially Equivalent	Anaerobe Systems
K790623	LOMBARD-DOWELL MILK AGAR	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790618	LOMBARD-DOWELL STARCH AGAR	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790229	VAGINALIS, HAEMOPHILUS	Feb 26, 1979	Substantially Equivalent	Los Angeles Biological Products
K780615	BLOOD CULTURE MEDIA	May 04, 1978	Substantially Equivalent	Meda Stat Diagnostics, Inc.
K771936	MICROBIOLOGICAL CULTURE MEDIUM	Dec 06, 1977	Substantially Equivalent	Scott Laboratories, Inc.
K771686	UREAPLASMA DIFFERENTIAL BASAL AGAR MED.	Oct 28, 1977	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.