Cleared Traditional

BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

K982328 · Bayer Corp. · Chemistry

Jan 1999

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K982328 is an FDA 510(k) clearance for the BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), a Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJO), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on January 29, 1999, 211 days after receiving the submission on July 2, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number	K982328 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 1998
Decision Date	January 29, 1999
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	CJO — Alpha-naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1050