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FDA 510(k)

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

K-Number: K011963 · 2001-11-20

ApplicantBayer Corp.
Decision Date2001-11-20
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2001-11-20 under 510(k) number K011963. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY?

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is Bayer Corp.. The 510(k) number is K011963.

When did ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY receive FDA 510(k) clearance?

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY received FDA 510(k) clearance on 2001-11-20, under 510(k) number K011963.

Who is the listed applicant for ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY?

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 ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY?

The FDA product code for ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY is CFR.

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Other records listing Bayer Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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Related Devices (Code: CFR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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.

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