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FDA 510(k)

RADIAS TSH ENZYME IMMUNOASSAY

K-Number: K931061 · 1993-06-16

ApplicantBio-Rad
Decision Date1993-06-16
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIAS TSH ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1993-06-16 under 510(k) number K931061. 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 RADIAS TSH ENZYME IMMUNOASSAY?

RADIAS TSH ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1993-06-16. The listed applicant is Bio-Rad. The 510(k) number is K931061.

When did RADIAS TSH ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

RADIAS TSH ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1993-06-16, under 510(k) number K931061.

Who is the listed applicant for RADIAS TSH ENZYME IMMUNOASSAY?

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

What is the FDA product code for RADIAS TSH ENZYME IMMUNOASSAY?

The FDA product code for RADIAS TSH ENZYME IMMUNOASSAY is JLW.

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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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