ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE— 510(k) K981897

Name: FDA 510(k) clearance K981897
Creator: U.S. Food and Drug Administration
Published: 1998-08-26

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K981897 for ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE, Substantially Equivalent on 1998-08-26. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1998-06-01
Decision date: 1998-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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