MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)
FDA 510(k) clearance K870649 · decided 1987-04-14
Clearance details
- K-number
- K870649
- Device name
- MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.)
- Applicant
- Hardy Media
- Decision
- Substantially Equivalent
- Date received
- 1987-02-13
- Decision date
- 1987-04-14
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- JTZ
- Device class
- 2
- Regulation number
- 866.1700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MUELLER HINTON AGAR (K132491) | Edge Biologicals, Inc. | 2014-06-30 |
| MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD (K963036) | Becton Dickinson Microbiology Systems | 1996-10-07 |
| MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (K960420) | Becton Dickinson Microbiology Systems | 1996-04-04 |
| MUELLER HINTON AGAR WITH 2% NACI (K960313) | Remel, L.P. | 1996-03-25 |
| CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (K945911) | Bioclinical Systems, Inc. | 1995-04-04 |
| MUELLER HINTON AGAR W/OXACILLIN (K941985) | Carr-Scarborough Microbiologicals, Inc. | 1994-08-24 |
| MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 (K882351) | Lakewood Biochemical Co., Inc. | 1988-06-28 |
| MULLER HINTON BROTH (K880105) | Hardy Media | 1988-03-30 |
| MUELLER HINTON MEDIA (K873268) | Central Media | 1987-11-04 |
| CHOCOLATE MUELLER HINTON AGAR (K871097) | bioMerieux, Inc. | 1987-04-03 |
| MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (K864247) | Mds Laboratories, Inc. | 1987-03-31 |
| MUELLER HINTON AGAR LARGE (K864246) | Mds Laboratories, Inc. | 1987-03-31 |
Recalls involving this device
No recalls on record reference this clearance.