ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION
FDA 510(k) clearance K894712 · decided 1989-11-14
Clearance details
- K-number
- K894712
- Device name
- ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION
- Applicant
- Gen-Probe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-26
- Decision date
- 1989-11-14
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- LQO
- Device class
- 1
- Regulation number
- 866.3110
- 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 |
|---|---|---|
| SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (K873670) | Molecular Biosystems, Inc. | 1988-06-08 |
| VIROGEN CMV ANTIBODY TEST (K875101) | Wampole Laboratories | 1988-03-01 |
| GENE-TRAK CAMPYLOBACTER ASSAY (K863270) | Integrated Genetics | 1987-08-31 |
Recalls involving this device
No recalls on record reference this clearance.
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 |