CHLAMYDIATROL AG
FDA 510(k) clearance K972129 · decided 1997-08-12
Clearance details
- K-number
- K972129
- Device name
- CHLAMYDIATROL AG
- Applicant
- Blackhawk Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-06
- Decision date
- 1997-08-12
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- MJZ
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Ramon, CA, 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 |
| ABBOTT STREP A CONTROLS (K972182) | Abbott Diagnostics | 1997-08-13 |
Recalls involving this device
No recalls on record reference this clearance.