INTRAY GC
FDA 510(k) clearance K993033 · decided 1999-12-16
Clearance details
- K-number
- K993033
- Device name
- INTRAY GC
- Applicant
- Biomed Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-09
- Decision date
- 1999-12-16
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- JTY
- Device class
- 2
- Regulation number
- 866.2410
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Jose, 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 |
|---|---|---|
| InTray GC (K210511) | Biomed Diagnostics Incorporated | 2021-10-20 |
| GC BASE W/ 1% GCHI (K954986) | Remel, L.P. | 1996-02-16 |
| CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (K950196) | Bioclinical Systems, Inc. | 1995-06-30 |
| MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (K933122) | Bioclinical Systems, Inc. | 1994-02-09 |
| MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (K933121) | Bioclinical Systems, Inc. | 1994-02-03 |
| THAYER MARTIN, MODIFIED PILL POCKET (K934331) | Hardy Diagnostics | 1993-12-21 |
| TRANSGROW (K934330) | Hardy Diagnostics | 1993-12-17 |
| MARTIN LEWIS WITH LINOCMYCIN (K931864) | Hardy Diagnostics | 1993-12-15 |
| CASMAN MEDIUM BASE (K881527) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PROTEOSE NO. 3 AGAR (K881552) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 (K871541) | Gibco Laboratories Life Technologies, Inc. | 1987-04-29 |
| THAYER MARTIN AGAR (K864253) | Mds Laboratories, Inc. | 1987-03-31 |
Recalls involving this device
No recalls on record reference this clearance.