MICROCOAGULATION PROTHROMBIN TIME TEST
FDA 510(k) clearance K940432 · decided 1994-05-18
Clearance details
- K-number
- K940432
- Device name
- MICROCOAGULATION PROTHROMBIN TIME TEST
- Applicant
- International Technidyne Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-31
- Decision date
- 1994-05-18
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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