Cleared Traditional

ACID PHOSPHATASE REAGENT SET

K821526 · Anco Medical Reagents & Assoc. · Chemistry
Jun 1982
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K821526 is an FDA 510(k) clearance for the ACID PHOSPHATASE REAGENT SET, a Acid Phosphatase, Thymolphthale Inmonophosphate (Class II — Special Controls, product code CKE), submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on June 10, 1982, 20 days after receiving the submission on May 21, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K821526 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1982
Decision Date June 10, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKE — Acid Phosphatase, Thymolphthale Inmonophosphate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1020

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