Cleared Traditional

DMA AMYLASE (DEMAND) PROCEDURE

K940010 · Data Medical Associates, Inc. · Chemistry
Mar 1994
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K940010 is an FDA 510(k) clearance for the DMA AMYLASE (DEMAND) PROCEDURE, a Saccharogenic, Amylase (Class II — Special Controls, product code CIJ), submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on March 11, 1994, 66 days after receiving the submission on January 4, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K940010 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1994
Decision Date March 11, 1994
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIJ — Saccharogenic, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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