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FDA 510(k)

3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K-Number: K981312 · 1998-06-05

ApplicantBayer Corp.
Decision Date1998-06-05
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1998-06-05 under 510(k) number K981312. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-05. The listed applicant is Bayer Corp.. The 510(k) number is K981312.

When did 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM receive FDA 510(k) clearance?

3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM received FDA 510(k) clearance on 1998-06-05, under 510(k) number K981312.

Who is the listed applicant for 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

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 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

The FDA product code for 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is JLW.

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Other records listing Bayer Corp. as applicant

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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: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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.

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