THROMBO-CALIBRATOR KIT
FDA 510(k) clearance K921344 · decided 1992-06-09
Clearance details
- K-number
- K921344
- Device name
- THROMBO-CALIBRATOR KIT
- Applicant
- American Bioproducts Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-19
- Decision date
- 1992-06-09
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.