CERTAIN(R) ELITE LEVEL 1, 2 AND 3— 510(k) K946224

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K946224 for CERTAIN(R) ELITE LEVEL 1, 2 AND 3, Substantially Equivalent on 1995-01-30. Applicant: Ciba Corning Diagnostics Corp..

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code JJS
Advisory panel: Clinical Chemistry
Date received: 1994-11-14
Decision date: 1995-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

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