FDA 510(k)

BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)

K-Number: K012340 · 2001-10-01

Decision Date2001-10-01

Product CodeJMO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2001-10-01 under 510(k) number K012340. The device is classified under product code JMO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)?

BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) is a medical device that received FDA 510(k) clearance on 2001-10-01. The listed applicant is Bayer Corp.. The 510(k) number is K012340.

When did BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) receive FDA 510(k) clearance?

BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) received FDA 510(k) clearance on 2001-10-01, under 510(k) number K012340.

Who is the listed applicant for BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)?

The FDA 510(k) record lists Bayer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)?

The FDA product code for BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) is JMO.

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Other records listing Bayer Corp. as applicant

K024062ASCENSIA BREEZE BLOOD GLUCOSE METER K023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST K024017BAYER ADVIA CENTAUR HER-2/NEU ASSAY K024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM K023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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Related Devices (Code: JMO)

K113438ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K061464VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668Ortho-Clinical Diagnostics, Inc.K052867VITROS CHEMISTRY PRODUCTS DTIBC REAGENTOrtho-Clinical Diagnostics, Inc.K041793OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524Olympus America, Inc.K013102WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002Wiener Laboratories Saic K000781DIRECT TIBC KITReference Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.