POLY-CHEM 90 TOTAL BILIRUBIN— 510(k) K111143
Substantially EquivalentPolymedco, Inc.
FDA 510(k) clearance K111143 for POLY-CHEM 90 TOTAL BILIRUBIN, Substantially Equivalent on 2011-09-01. Applicant: Polymedco, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymedco, Inc.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
Recent devices under product code CIG
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- K090703 — POLY-CHEM 90 GLUCOSE
- K061944 — POLY-CHEM CREATININE
Data sourced from openFDA. This site is unofficial and independent of the FDA.