IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)— 510(k) K110889

Substantially Equivalent

Ind Diagnostics, Inc.

FDA 510(k) clearance K110889 for IND ONE STEP HCG URINE PREGNANCY TEST (STRIP), Substantially Equivalent on 2011-06-20. Applicant: Ind Diagnostics, Inc..

Clearance details

Applicant: Ind Diagnostics, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2011-03-30
Decision date: 2011-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delta, B.C., CA

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