ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
FDA 510(k) clearance K092704 · decided 2010-05-28
Clearance details
- K-number
- K092704
- Device name
- ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
- Applicant
- Abbott Molecular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-03
- Decision date
- 2010-05-28
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- LSK
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Des Plaines, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Molecular
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 |
|---|---|---|
| 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 |
| 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 |
| 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 |
|---|---|---|
| Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Pl recall (Z-1397-2011) | Abbott Molecular | 2011-02-23 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Alinity m HR HPV (P230003/S009) | Abbott Molecular, Inc. | 2025-10-17 |
| Alinity m HBV (P200013/S027) | Abbott Molecular, Inc. | 2025-10-17 |
| Alinity m HR HPV (P230003/S008) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HBV (P200013/S026) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HR HPV (P230003/S006) | Abbott Molecular, Inc. | 2025-09-10 |
| Vysis CLL Fish Probe Kit (P150041/S007) | Abbott Molecular, Inc. | 2025-08-08 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S022) | Abbott Molecular, Inc. | 2025-08-05 |
| Alinity m HR HPV (P230003/S007) | Abbott Molecular, Inc. | 2025-04-18 |