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FDA 510(k)

RADIAS TOTAL T4 ENZYME IMMUNOASSAY

K-Number: K946163 · 1995-02-22

ApplicantBio-Rad
Decision Date1995-02-22
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIAS TOTAL T4 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 1995-02-22 under 510(k) number K946163. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIAS TOTAL T4 ENZYME IMMUNOASSAY?

RADIAS TOTAL T4 ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1995-02-22. The listed applicant is Bio-Rad. The 510(k) number is K946163.

When did RADIAS TOTAL T4 ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

RADIAS TOTAL T4 ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1995-02-22, under 510(k) number K946163.

Who is the listed applicant for RADIAS TOTAL T4 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 TOTAL T4 ENZYME IMMUNOASSAY?

The FDA product code for RADIAS TOTAL T4 ENZYME IMMUNOASSAY is KLI.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman 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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