SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)— 510(k) K911628

Name: FDA 510(k) clearance K911628
Creator: U.S. Food and Drug Administration
Published: 1991-06-27

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K911628 for SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%), Substantially Equivalent on 1991-06-27. 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: 1991-04-11
Decision date: 1991-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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