510(k) K082977— BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

Substantially Equivalent

Mk Bio, Inc.

Clearance details

Applicant: Mk Bio, Inc.
Product code: Code LDJ
Advisory panel: Clinical Toxicology
Date received: 2008-10-06
Decision date: 2009-08-20
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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