JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Microbiology · 21 CFR 866.1700 · Class 2
Overview
| Product Code | JTZ |
|---|---|
| Device Name | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth |
| Regulation | 21 CFR 866.1700 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 74)
Showing 20 most recent of 74 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132491 | MUELLER HINTON AGAR | Edge Biologicals, Inc. | Jun 30, 2014 | SESE |
| K963036 | MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD | Becton Dickinson Microbiology Systems | Oct 7, 1996 | SESE |
| K960420 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | Becton Dickinson Microbiology Systems | Apr 4, 1996 | SESE |
| K960313 | MUELLER HINTON AGAR WITH 2% NACI | Remel, L.P. | Mar 25, 1996 | SESE |
| K945911 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS | Bioclinical Systems, Inc. | Apr 4, 1995 | SESE |
| K941985 | MUELLER HINTON AGAR W/OXACILLIN | Carr-Scarborough Microbiologicals, Inc. | Aug 24, 1994 | SESE |
| K882351 | MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 | Lakewood Biochemical Co., Inc. | Jun 28, 1988 | SESE |
| K880105 | MULLER HINTON BROTH | Hardy Media | Mar 30, 1988 | SESE |
| K873268 | MUELLER HINTON MEDIA | Central Media | Nov 4, 1987 | SESE |
| K870649 | MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.) | Hardy Media | Apr 14, 1987 | SESE |
| K871097 | CHOCOLATE MUELLER HINTON AGAR | bioMerieux, Inc. | Apr 3, 1987 | SESE |
| K864248 | MUELLER HINTON AGAR - SUPPLEMENTED | Mds Laboratories, Inc. | Mar 31, 1987 | SESE |
| K864247 | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | Mds Laboratories, Inc. | Mar 31, 1987 | SESE |
| K864246 | MUELLER HINTON AGAR LARGE | Mds Laboratories, Inc. | Mar 31, 1987 | SESE |
| K864245 | MUELLER HINTON AGAR SMALL | Mds Laboratories, Inc. | Mar 31, 1987 | SESE |
| K863821 | MUELLER HINTON AGAR W/4%NACL AND OXACILLIN | Gibco Laboratories Life Technologies, Inc. | Oct 9, 1986 | SESE |
| K861301 | BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 | Troy Biologicals, Inc. | Apr 21, 1986 | SESE |
| K854521 | BIOGRAM | Giles Scientific, Inc. | Dec 23, 1985 | SESE |
| K854451 | MUELLER HINTON MEDIUM | R. Kent Richards, Inc. | Nov 18, 1985 | SESE |
| K853238 | APL MUELLER HINTON AGAR | Apl Medical Supplies | Aug 19, 1985 | SESE |
Top Applicants
- Hardy Media — 5 clearances
- Biomedia, Inc. — 5 clearances
- Mds Laboratories, Inc. — 4 clearances
- Isle Media and Sterile Products, Inc. — 3 clearances
- Interstate Media — 3 clearances
