ONE STEP LH TEST— 510(k) K935134

Substantially Equivalent

Tcpi, Inc.

FDA 510(k) clearance K935134 for ONE STEP LH TEST, Substantially Equivalent on 1994-01-11. Applicant: Tcpi, Inc..

Clearance details

Applicant: Tcpi, Inc.
Product code: Code CEP
Advisory panel: Clinical Chemistry
Date received: 1993-10-28
Decision date: 1994-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

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