RENCTK— 510(k) K800774

Substantially Equivalent

Sorin Biomedica, Fiat, USA, Inc.

FDA 510(k) clearance K800774 for RENCTK, Substantially Equivalent on 1980-04-21. Applicant: Sorin Biomedica, Fiat, USA, Inc..

Clearance details

Applicant: Sorin Biomedica, Fiat, USA, Inc.
Product code: Code CIB
Advisory panel: Clinical Chemistry
Date received: 1980-04-07
Decision date: 1980-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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