ABBOTT STREP A CONTROLS
FDA 510(k) clearance K972182 · decided 1997-08-13
Clearance details
- K-number
- K972182
- Device name
- ABBOTT STREP A CONTROLS
- Applicant
- Abbott Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1997-05-29
- Decision date
- 1997-08-13
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- MJZ
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (K083744) | Binax, Inc. | 2009-09-01 |
| CHLAMYDIATROL AG (K972129) | Blackhawk Biosystems, Inc. | 1997-08-12 |
Recalls involving this device
No recalls on record reference this clearance.