Cleared Traditional

ACID PHOSPHATASE REAGENT SET

K860476 · Sterling Diagnostics, Inc. · Chemistry
Mar 1986
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K860476 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 Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on March 5, 1986, 26 days after receiving the submission on February 7, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number K860476 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1986
Decision Date March 05, 1986
Days to Decision 26 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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