COULTER ACCU-ZYME IIY-GT REAGENT KIT— 510(k) K790812

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K790812 for COULTER ACCU-ZYME IIY-GT REAGENT KIT, Substantially Equivalent on 1979-06-28. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant
Coulter Electronics, Inc.
Product code
Code JPZ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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