VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT— 510(k) K900688

Name: FDA 510(k) clearance K900688
Creator: U.S. Food and Drug Administration
Published: 1990-05-15

Substantially Equivalent

Clinical Sciences, Inc.

FDA 510(k) clearance K900688 for VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT, Substantially Equivalent on 1990-05-15. Applicant: Clinical Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Sciences, Inc.
Product code: Code LFY
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1990-02-13
Decision date: 1990-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whippany, NJ, US

Download summary PDF View on FDA.gov ↗

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