COAG-I ANALYZER, ALPHA MODEL
FDA 510(k) clearance K882444 · decided 1988-08-25
Clearance details
- K-number
- K882444
- Device name
- COAG-I ANALYZER, ALPHA MODEL
- Applicant
- Cardiovascular Diagnostic Services
- Decision
- Substantially Equivalent
- Date received
- 1988-06-14
- Decision date
- 1988-08-25
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Research Triangle Park, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.