COULTER ACCU-ZYME II GPT REAGENT— 510(k) K790522

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K790522 for COULTER ACCU-ZYME II GPT REAGENT, Substantially Equivalent on 1979-05-01. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code CKA
Advisory panel: Clinical Chemistry
Date received: 1979-03-09
Decision date: 1979-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.