OSOM PREGNANCY TEST— 510(k) K954178

Substantially Equivalent

Wyntek Diagnostics, Inc.

FDA 510(k) clearance K954178 for OSOM PREGNANCY TEST, Substantially Equivalent on 1995-10-23. Applicant: Wyntek Diagnostics, Inc..

Clearance details

Applicant: Wyntek Diagnostics, Inc.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 1995-09-05
Decision date: 1995-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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