POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
FDA 510(k) clearance K110818 · decided 2011-09-08
Clearance details
- K-number
- K110818
- Device name
- POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
- Applicant
- Polymedco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-24
- Decision date
- 2011-09-08
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- CIX
- Device class
- 2
- Regulation number
- 862.1035
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cortlandt Manor, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.