QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)
FDA 510(k) clearance K944452 · decided 1994-12-02
Clearance details
- K-number
- K944452
- Device name
- QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-12
- Decision date
- 1994-12-02
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.