URIC ACID REFERENCE SERA
FDA 510(k) clearance K780447 · decided 1978-06-22
Clearance details
- K-number
- K780447
- Device name
- URIC ACID REFERENCE SERA
- Applicant
- Macomb Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-20
- Decision date
- 1978-06-22
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- 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.