Cleared Traditional

ACID PHOSPHATASE REAGENT SET

K915705 · Tech Intl. Co. · Chemistry
Feb 1992
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K915705 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 Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on February 27, 1992, 90 days after receiving the submission on November 29, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K915705 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1991
Decision Date February 27, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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