SEROLISA CHLAMYDIA IGG TEST KIT— 510(k) K915281

Name: FDA 510(k) clearance K915281
Creator: U.S. Food and Drug Administration
Published: 1992-03-23

Substantially Equivalent

Savyon Diagnostics , Ltd.

FDA 510(k) clearance K915281 for SEROLISA CHLAMYDIA IGG TEST KIT, Substantially Equivalent on 1992-03-23. Applicant: Savyon Diagnostics , Ltd.. Device class: 1.

Clearance details

Applicant: Savyon Diagnostics , Ltd.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1991-11-25
Decision date: 1992-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheva, Israel, IL

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K910644 — IPAZYME (TM) CHLAMYDIA IGG-IGA1991-03-19
K901975 — IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)1991-03-08

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