Cleared Traditional

ALKALINE PHOSPHATASE REAGENT SET

K843332 · Sterling Biochemical, Inc. · Chemistry
Sep 1984
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K843332 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE REAGENT SET, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Sterling Biochemical, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1984, 18 days after receiving the submission on August 27, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K843332 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1984
Decision Date September 14, 1984
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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