BARTELS CYTOMEGALOVIRUS IGM EIA— 510(k) K922580

Name: FDA 510(k) clearance K922580
Creator: U.S. Food and Drug Administration
Published: 1993-04-08

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K922580 for BARTELS CYTOMEGALOVIRUS IGM EIA, Substantially Equivalent on 1993-04-08. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code LKQ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1992-05-27
Decision date: 1993-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

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