ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.
FDA 510(k) clearance K902213 · decided 1990-08-06
Clearance details
- K-number
- K902213
- Device name
- ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.
- Applicant
- Gen-Probe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-16
- Decision date
- 1990-08-06
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- MCS
- Device class
- 1
- Regulation number
- 866.3700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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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 |