Cleared Traditional

AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)

K951494 · Emd Chemicals, Inc. · Chemistry
Dec 1995
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K951494 is an FDA 510(k) clearance for the AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR), a Saccharogenic, Amylase (Class II — Special Controls, product code CIJ), submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 11, 1995, 255 days after receiving the submission on March 31, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K951494 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1995
Decision Date December 11, 1995
Days to Decision 255 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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