Product Code: JSE FDA class 1 21 CFR 866.2320

Culture Media, Multiple Biochemical Test

Microbiology

The Culture Media, Multiple Biochemical Test is a microbiology diagnostic medium designed to perform multiple biochemical reactions simultaneously in a single inoculation, enabling the identification of microorganisms based on a pattern of metabolic reactions used to differentiate bacterial species in clinical microbiology laboratories. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JSE and is regulated under 21 CFR 866.2320, within the Microbiology medical specialty.

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Basic Information

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

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K962265	MLX MICROTITER PLATE LUMINOMETER	Jul 25, 1996	Substantially Equivalent	Dynatech Laboratories, Inc.
K883996	X-ACT LDC/IND	Oct 12, 1988	Substantially Equivalent	Pro-Lab, Inc.
K883995	X-ACT UREA/TDA	Oct 12, 1988	Substantially Equivalent	Pro-Lab, Inc.
K880133	MIL MEDIUM	Mar 31, 1988	Substantially Equivalent	Hardy Media
K880116	MRVP BROTH	Mar 31, 1988	Substantially Equivalent	Hardy Media
K874537	KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR	Nov 20, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K871096	CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K864674	MICRODILUTION IDENTIFICATION PANELS	Jan 05, 1987	Substantially Equivalent	American Micro Scan
K862393	BIOTIS LITMUS MILK	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860415	BIOTIS SIMMON CITRATE AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860414	BIOTIS ORNITHINE INDOLE MOTILITY MEDIA	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860413	BIOTIS TSI	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860412	BIOTIS SIM MEDIUM	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860194	AUSTIN ENTERIC SYSTEM	Feb 20, 1986	Substantially Equivalent	Austin Biological Laboratories
K850982	CTAPI - NEISSERA SCREEN	Mar 29, 1985	Substantially Equivalent	Analytical Products, Inc.
K850734	DIFFERENTIAL CULTURE MEDIUM	Mar 20, 1985	Substantially Equivalent	Roseville Medical Laboratoriesu
K850551	SIM MEDIUM	Mar 11, 1985	Substantially Equivalent	Hardy Media
K850548	LYSINE IRON AGAR LIA	Mar 11, 1985	Substantially Equivalent	Hardy Media
K850547	MOTILITY INDOLE ORNITHINE AGAR	Mar 11, 1985	Substantially Equivalent	Hardy Media
K850546	KLIGLER IRON AGAR KIA	Mar 11, 1985	Substantially Equivalent	Hardy Media
K843768	BIOTIS KLIGLER IRON AGAR	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K842451	RIM STREP KIT	Jul 02, 1984	Substantially Equivalent	Austin Biological Laboratories
K842424	BIOTIS LD-PRESUMPTO QUADRANT PLATE	Jul 02, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K841204	MULTIPLE BIOCHEMICAL TEST	Apr 17, 1984	Substantially Equivalent	Smith River Biologicals
K834012	SIM MEDIUM	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K834004	MYCOBIOTIC AGAR	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K834003	MOTILITY INDOLE ORNITHINE-MEDIUM	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K834002	LYSINE IRON AGAR	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K834001	KLIGLER IRON AGAR	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K832568	INDOLE NITRATE MEDIUM	Sep 12, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K830525	API 20GP	May 18, 1983	Substantially Equivalent	Analytical Products, Inc.
K822998	CHRISTENSENS CITRATE SULFIDE AGAR	Nov 16, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K823072	LECITHIN LACTOSE AGAR	Nov 05, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K821592	TRIPLE SUGAR IRON AGAR SLANT	Jul 08, 1982	Substantially Equivalent	Hardy Media
K820842	CULTURE MEDIA, NON-SELECTIVE/DIFFER	Apr 16, 1982	Substantially Equivalent	Blue Ridge Media Co.
K820841	CULTURE MEDIA, MULTIPLE BIOCHEMICAL	Apr 16, 1982	Substantially Equivalent	Blue Ridge Media Co.
K820810	#4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820214	SUCROSE	Feb 05, 1982	Substantially Equivalent	Dms Laboratories
K812911	BCYE MEDIUM	Nov 06, 1981	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K812467	PGUA-INDOL MICROTUBE	Sep 14, 1981	Substantially Equivalent	Carr Microbiologicals
K812466	ONPX-INDOL MEDIUM MICROTUBES	Sep 14, 1981	Substantially Equivalent	Carr Microbiologicals
K800734	RAPID FERMENTATION AGAR (RFA)	May 08, 1980	Substantially Equivalent	Remel Co.
K792420	SIM MEDIUM	Dec 31, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792425	DECARBOXYLASE MOELLER BASE WITH OR WITH-	Dec 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791473	TRIPLE SUGAR IRON AGAR (TSI AGAR)	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791222	API 20E REAGENT QC	Aug 22, 1979	Substantially Equivalent	Analytical Products, Inc.
K790617	CARBOHYDRATE FERMENTATION MEDIA	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790232	AGAR, MOTILITY-NITRATE	Feb 21, 1979	Substantially Equivalent	Los Angeles Biological Products
K790230	DENTRIFICATION LACTOSE AGAR	Feb 21, 1979	Substantially Equivalent	Los Angeles Biological Products
K781856	PLATE, LD PRESUMPTO	Nov 22, 1978	Substantially Equivalent	Anaerobe Systems
K770989	API 50 E	Jun 29, 1977	Substantially Equivalent	Analytical Products, Inc.
K770746	PANEL, IDENTIFICATION, STREP, MICRO-ID	Jun 23, 1977	Substantially Equivalent	Micro-Media Systems, Inc.
K770176	API 3S	Feb 18, 1977	Substantially Equivalent	Analytical Products, Inc.