SNAP MYCOBACTERIA AVIUM COMPLEX
FDA 510(k) clearance K900202 · decided 1990-04-03
Clearance details
- K-number
- K900202
- Device name
- SNAP MYCOBACTERIA AVIUM COMPLEX
- Applicant
- Syngene, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-16
- Decision date
- 1990-04-03
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LQF
- Device class
- 1
- Regulation number
- 866.3370
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, 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 |
|---|---|---|
| ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K921435) | Gen-Probe, Inc. | 1992-07-23 |
| ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST (K904463) | Gen-Probe, Inc. | 1990-11-13 |
| ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE (K897077) | Gen-Probe, Inc. | 1990-08-23 |
| ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST (K896494) | Gen-Probe, Inc. | 1990-08-23 |
| ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K897078) | Gen-Probe, Inc. | 1990-05-02 |
| ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST (K896492) | Gen-Probe, Inc. | 1990-04-16 |
| ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST (K896493) | Gen-Probe, Inc. | 1990-04-11 |
| SNAP M. TUBERCULOSIS COMPLEX (K900292) | Syngene, Inc. | 1990-04-03 |
| RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE (K890089) | Gen-Probe, Inc. | 1989-03-13 |
| RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. (K871795) | Gen-Probe, Inc. | 1987-07-30 |
| GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA (K864597) | Gen-Probe, Inc. | 1987-04-20 |
| RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX (K862613) | Gen-Probe, Inc. | 1986-11-10 |
Recalls involving this device
No recalls on record reference this clearance.