BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)— 510(k) K992136

Name: FDA 510(k) clearance K992136
Creator: U.S. Food and Drug Administration
Published: 1999-11-09

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K992136 for BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS), Substantially Equivalent on 1999-11-09. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code CIT
Device class: Class 2
Regulation: 21 CFR 862.1100
Advisory panel: Clinical Chemistry
Date received: 1999-06-24
Decision date: 1999-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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