ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
FDA 510(k) clearance K080739 · decided 2008-07-10
Clearance details
- K-number
- K080739
- Device name
- ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
- Applicant
- Abbott Molecular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-17
- Decision date
- 2008-07-10
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- MKZ
- 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.
Recalls involving this device
No recalls on record reference this clearance.
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 |