Cleared Traditional

VITALAB AMYLASE REAGENT

K040534 · Clinical Data, Inc. · Chemistry
Mar 2004
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K040534 is an FDA 510(k) clearance for the VITALAB AMYLASE REAGENT, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on March 11, 2004, 9 days after receiving the submission on March 2, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K040534 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2004
Decision Date March 11, 2004
Days to Decision 9 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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