ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
FDA 510(k) clearance K973678 · decided 1997-12-15
Clearance details
- K-number
- K973678
- Device name
- ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
- Applicant
- Sorrento Biochemical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-26
- Decision date
- 1997-12-15
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.