Cleared Traditional

CARESIDE AMYLASE

K990025 · Careside, Inc. · Chemistry
Feb 1999
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K990025 is an FDA 510(k) clearance for the CARESIDE AMYLASE, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on February 8, 1999, 35 days after receiving the submission on January 4, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K990025 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1999
Decision Date February 08, 1999
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFJ — Catalytic Methods, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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