LYME IGM ELISA TEST SYSTEM— 510(k) K900196

Name: FDA 510(k) clearance K900196
Creator: U.S. Food and Drug Administration
Published: 1990-05-02

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K900196 for LYME IGM ELISA TEST SYSTEM, Substantially Equivalent on 1990-05-02. Applicant: Zeus Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1990-01-16
Decision date: 1990-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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