LYME STAT M TEST KIT— 510(k) K904652

Name: FDA 510(k) clearance K904652
Creator: U.S. Food and Drug Administration
Published: 1991-10-21

Substantially Equivalent

Whittaker Bioproducts, Inc.

FDA 510(k) clearance K904652 for LYME STAT M TEST KIT, Substantially Equivalent on 1991-10-21. Applicant: Whittaker Bioproducts, Inc.. Device class: 2.

Clearance details

Applicant: Whittaker Bioproducts, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1990-10-15
Decision date: 1991-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

Download summary PDF View on FDA.gov ↗

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