ANTIGENZ CHLAMYDIA— 510(k) K912680

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K912680 for ANTIGENZ CHLAMYDIA, Substantially Equivalent on 1991-07-22. Applicant: Baxter Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1991-06-03
Decision date: 1991-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

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