Cleared Traditional

EMDS ALKANINE PHOSPHATASE (ALP) TEST

K935182 · Em Diagnostic Systems, Inc. · Chemistry
Dec 1993
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K935182 is an FDA 510(k) clearance for the EMDS ALKANINE PHOSPHATASE (ALP) TEST, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 9, 1993, 43 days after receiving the submission on October 27, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K935182 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1993
Decision Date December 09, 1993
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

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