PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST— 510(k) K971825

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K971825 for PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST, Substantially Equivalent on 1997-07-24. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1997-05-16
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

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