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

Substantially Equivalent

Handylab, Inc.

Clearance details

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

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