PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
FDA 510(k) clearance K920378 · decided 1992-04-29
Clearance details
- K-number
- K920378
- Device name
- PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
- Applicant
- Gen-Probe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-29
- Decision date
- 1992-04-29
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- LSK
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| HYBRID CAPTURE II CT-ID TEST (K990023) | Digene Corp. | 1999-10-25 |
| PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY (K920302) | Gen-Probe, Inc. | 1994-04-06 |
| GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS (K874878) | Gen-Probe, Inc. | 1987-12-29 |
| RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS (K871878) | Gen-Probe, Inc. | 1987-10-28 |
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 |