POLY-CHEM GLUCOSE— 510(k) K020852
Substantially EquivalentPolymedco, Inc.
FDA 510(k) clearance K020852 for POLY-CHEM GLUCOSE, Substantially Equivalent on 2002-07-03. Applicant: Polymedco, Inc.. Device class: 2.
Clearance details
- Applicant
- Polymedco, Inc.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
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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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.