Cleared Traditional

ALKALINE PHOSPHOTASE REAGENT SET

K841064 · Medical Specialties, Inc. · Chemistry

May 1984

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K841064 is an FDA 510(k) clearance for the ALKALINE PHOSPHOTASE REAGENT SET, a Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CIO), submitted by Medical Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984, 50 days after receiving the submission on March 12, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K841064 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 1984
Decision Date	May 01, 1984
Days to Decision	50 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