ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
FDA 510(k) clearance K896493 · decided 1990-04-11
Clearance details
- K-number
- K896493
- Device name
- ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
- Applicant
- Gen-Probe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-11-13
- Decision date
- 1990-04-11
- Days to decision
- 149 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 |
| SNAP MYCOBACTERIA AVIUM COMPLEX (K900202) | Syngene, Inc. | 1990-04-03 |
| 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
| Record | Firm | Date |
|---|---|---|
| Mycobacterium Tuberculosis Complex Culture Identification Test, 2860. recall (Z-1438-2011) | Gen-Probe Inc | 2011-03-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S019) | Gen-Probe, Inc. | 2012-12-05 |
| AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S018) | Gen-Probe, Inc. | 2010-04-23 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD) (P940034/S017) | Gen-Probe, Inc. | 2007-07-18 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S016) | Gen-Probe, Inc. | 2004-10-08 |
| GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S015) | Gen-Probe, Inc. | 2004-02-10 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST) (P940034/S013) | Gen-Probe, Inc. | 2002-01-25 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S012) | Gen-Probe, Inc. | 2001-08-30 |
| GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S011) | Gen-Probe, Inc. | 2000-11-21 |