BARTELS LYME DISEASE IGM EIA— 510(k) K922578

Name: FDA 510(k) clearance K922578
Creator: U.S. Food and Drug Administration
Published: 1992-09-02

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K922578 for BARTELS LYME DISEASE IGM EIA, Substantially Equivalent on 1992-09-02. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1992-05-27
Decision date: 1992-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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