HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB— 510(k) K090191

Name: FDA 510(k) clearance K090191
Creator: U.S. Food and Drug Administration
Published: 2010-05-27

Substantially Equivalent

Handylab, Inc.

FDA 510(k) clearance K090191 for HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB, Substantially Equivalent on 2010-05-27. Applicant: Handylab, Inc.. Device class: 1.

Clearance details

Applicant: Handylab, Inc.
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2009-01-27
Decision date: 2010-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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