URIC ACID (URICASE) METHOD-II
FDA 510(k) clearance K863287 · decided 1986-09-29
Clearance details
- K-number
- K863287
- Device name
- URIC ACID (URICASE) METHOD-II
- Applicant
- Catachem, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-25
- Decision date
- 1986-09-29
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JHC
- Device class
- 1
- Regulation number
- 862.1775
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Port Chester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.