HYBRID CAPTURE II CT-ID TEST
FDA 510(k) clearance K990023 · decided 1999-10-25
Clearance details
- K-number
- K990023
- Device name
- HYBRID CAPTURE II CT-ID TEST
- Applicant
- Digene Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-05
- Decision date
- 1999-10-25
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- LSK
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Beltsville, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Digene Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 (K092704) | Abbott Molecular, Inc. | 2010-05-28 |
| MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (K010891) | Digene Corp. | 2001-09-25 |
| MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (K010892) | Digene Corp. | 2001-09-24 |
| PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY (K920302) | Gen-Probe, Inc. | 1994-04-06 |
| PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS (K920378) | Gen-Probe, Inc. | 1992-04-29 |
| 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
| Record | Firm | Date |
|---|---|---|
| Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only). recall (Z-0657-03) | Digene Corp | 2003-03-19 |