CLOTTING TIME REAGENT
FDA 510(k) clearance K820084 · decided 1982-02-22
Clearance details
- K-number
- K820084
- Device name
- CLOTTING TIME REAGENT
- Applicant
- American Dade
- Decision
- Substantially Equivalent
- Date received
- 1982-01-12
- Decision date
- 1982-02-22
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- GJB
- Device class
- 2
- Regulation number
- 864.7875
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.