Cleared Traditional

SILYL AMYL

K931583 · Em Diagnostic Systems, Inc. · Chemistry
Aug 1993
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K931583 is an FDA 510(k) clearance for the SILYL AMYL, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on August 19, 1993, 141 days after receiving the submission on March 31, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K931583 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1993
Decision Date August 19, 1993
Days to Decision 141 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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