POLY-CHEM 90 ISE MODULE
FDA 510(k) clearance K112408 · decided 2011-11-04
Clearance details
- K-number
- K112408
- Device name
- POLY-CHEM 90 ISE MODULE
- Applicant
- Polymedco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-08-22
- Decision date
- 2011-11-04
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- CEM
- Device class
- 2
- Regulation number
- 862.1600
- 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.