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FDA 510(k)

BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY

K-Number: K983345 · 1998-12-07

ApplicantBayer Corp.
Decision Date1998-12-07
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1998-12-07 under 510(k) number K983345. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY?

BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Bayer Corp.. The 510(k) number is K983345.

When did BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY receive FDA 510(k) clearance?

BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY received FDA 510(k) clearance on 1998-12-07, under 510(k) number K983345.

Who is the listed applicant for BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY?

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 IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY?

The FDA product code for BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY is JJE.

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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: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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