OSOM MONO TEST 143— 510(k) K972231

Substantially Equivalent

Wyntek Diagnostics, Inc.

FDA 510(k) clearance K972231 for OSOM MONO TEST 143, Substantially Equivalent on 1997-08-26. Applicant: Wyntek Diagnostics, Inc..

Clearance details

Applicant: Wyntek Diagnostics, Inc.
Product code: Code KTN
Advisory panel: Immunology
Date received: 1997-06-16
Decision date: 1997-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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