POLY-CHEM 90 GLUCOSE— 510(k) K090703

Substantially Equivalent

Polymedco, Inc.

FDA 510(k) clearance K090703 for POLY-CHEM 90 GLUCOSE, Substantially Equivalent on 2009-10-20. 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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