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FDA 510(k)

THYROXINE ENZYME IMMUNOASSAY

K-Number: K944703 · 1994-12-09

ApplicantDiagnostic Reagents, Inc.
Decision Date1994-12-09
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYROXINE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1994-12-09 under 510(k) number K944703. 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 THYROXINE ENZYME IMMUNOASSAY?

THYROXINE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K944703.

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

THYROXINE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1994-12-09, under 510(k) number K944703.

Who is the listed applicant for THYROXINE ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Diagnostic Reagents, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THYROXINE ENZYME IMMUNOASSAY?

The FDA product code for THYROXINE ENZYME IMMUNOASSAY is KLI.

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Other records listing Diagnostic Reagents, Inc. 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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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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