Cleared Traditional

ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE

K981897 · Roche Diagnostic Systems, Inc. · Chemistry
Aug 1998
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K981897 is an FDA 510(k) clearance for the ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 26, 1998, 86 days after receiving the submission on June 1, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K981897 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1998
Decision Date August 26, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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