PROTHROMBIN TIME TEST
FDA 510(k) clearance K870596 · decided 1987-04-20
Clearance details
- K-number
- K870596
- Device name
- PROTHROMBIN TIME TEST
- Applicant
- U. S. Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-10
- Decision date
- 1987-04-20
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Luis Obispo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.