OSOM CARD PREGNANCY TEST, MODEL 103— 510(k) K990576

Substantially Equivalent

Wyntek Diagnostics, Inc.

FDA 510(k) clearance K990576 for OSOM CARD PREGNANCY TEST, MODEL 103, Substantially Equivalent on 1999-03-09. Applicant: Wyntek Diagnostics, Inc..

Clearance details

Applicant: Wyntek Diagnostics, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 1999-02-23
Decision date: 1999-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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