SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT— 510(k) K902227

Name: FDA 510(k) clearance K902227
Creator: U.S. Food and Drug Administration
Published: 1991-04-02

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K902227 for SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT, Substantially Equivalent on 1991-04-02. Applicant: Serim Research Corp.. Device class: 2.

Clearance details

Applicant: Serim Research Corp.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1990-05-17
Decision date: 1991-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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