POLY-CHEM 90 ISE MODULE— 510(k) K112408
Substantially EquivalentPolymedco, Inc.
FDA 510(k) clearance K112408 for POLY-CHEM 90 ISE MODULE, Substantially Equivalent on 2011-11-04. Applicant: Polymedco, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymedco, Inc.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
Recent devices under product code CEM
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- K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
- K090703 — POLY-CHEM 90 GLUCOSE
- K061944 — POLY-CHEM CREATININE
Data sourced from openFDA. This site is unofficial and independent of the FDA.