COULTER ACCU-ZYME II ENZYMATIC REAGENT— 510(k) K791640

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K791640 for COULTER ACCU-ZYME II ENZYMATIC REAGENT, Substantially Equivalent on 1979-09-24. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code CDT
Advisory panel: Clinical Chemistry
Date received: 1979-08-21
Decision date: 1979-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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