Cleared Traditional

COBAS STANDARDS FOR CALCIUM-IN-ORGANIC

K823578 · Hoffmann-La Roche, Inc. · Chemistry

Jan 1983

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K823578 is an FDA 510(k) clearance for the COBAS STANDARDS FOR CALCIUM-IN-ORGANIC, a Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CIO), submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983, 32 days after receiving the submission on December 6, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K823578 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 1982
Decision Date	January 07, 1983
Days to Decision	32 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