ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM— 510(k) K991907

Name: FDA 510(k) clearance K991907
Creator: U.S. Food and Drug Administration
Published: 1999-11-09

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K991907 for ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM, Substantially Equivalent on 1999-11-09. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code CZW
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 1999-06-07
Decision date: 1999-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CZW

view all

K100179 — SPAPLUS2010-08-13
K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL2007-03-19
K061852 — DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH2006-09-22
K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)2005-05-02
K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III2004-10-19

More clearances from Bayer Corp.

view all

K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER2003-03-03
K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST2003-02-11
K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY2003-01-30
K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL2003-01-23
K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM2002-12-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.