SERIM PYLORITEK REAGENT STRIPS— 510(k) K936034

Name: FDA 510(k) clearance K936034
Creator: U.S. Food and Drug Administration
Published: 1994-04-21

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K936034 for SERIM PYLORITEK REAGENT STRIPS, Substantially Equivalent on 1994-04-21. Applicant: Serim Research Corp.. Device class: 1.

Clearance details

Applicant: Serim Research Corp.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1993-12-15
Decision date: 1994-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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