STATZYME URIC ACID REAGENT
FDA 510(k) clearance K770831 · decided 1977-07-11
Clearance details
- K-number
- K770831
- Device name
- STATZYME URIC ACID REAGENT
- Applicant
- Worthington Biochemical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-06
- Decision date
- 1977-07-11
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- CDO
- Device class
- 1
- Regulation number
- 862.1775
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.