POLY-CHEM CREATININE
FDA 510(k) clearance K061944 · decided 2006-11-03
Clearance details
- K-number
- K061944
- Device name
- POLY-CHEM CREATININE
- Applicant
- Polymedco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-10
- Decision date
- 2006-11-03
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- JFY
- Device class
- 2
- Regulation number
- 862.1225
- 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.