Cleared Traditional

ALKALINE PHOSPHATASE REAGENT SET

K860351 · Sterling Diagnostics, Inc. · Chemistry

Feb 1986

Decision

12d

Days

Class 2

Risk

About This 510(k) Submission

K860351 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE REAGENT SET, a Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CIO), submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 11, 1986, 12 days after receiving the submission on January 30, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K860351 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1986
Decision Date	February 11, 1986
Days to Decision	12 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	CIO — Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1050