RAPICIDE OPA-28 TEST STRIP— 510(k) K120652

Name: FDA 510(k) clearance K120652
Creator: U.S. Food and Drug Administration
Published: 2012-10-12

Substantially Equivalent

Serim Research Corp.

FDA 510(k) clearance K120652 for RAPICIDE OPA-28 TEST STRIP, Substantially Equivalent on 2012-10-12. Applicant: Serim Research Corp.. Device class: 2.

Clearance details

Applicant: Serim Research Corp.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2012-03-02
Decision date: 2012-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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