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FDA 510(k)

CEDIA TOTAL T4 ASSAY

K-Number: K852164 · 1985-07-22

ApplicantMicrogenics Corp.
Decision Date1985-07-22
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CEDIA TOTAL T4 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1985-07-22 under 510(k) number K852164. 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 CEDIA TOTAL T4 ASSAY?

CEDIA TOTAL T4 ASSAY is a medical device that received FDA 510(k) clearance on 1985-07-22. The listed applicant is Microgenics Corp.. The 510(k) number is K852164.

When did CEDIA TOTAL T4 ASSAY receive FDA 510(k) clearance?

CEDIA TOTAL T4 ASSAY received FDA 510(k) clearance on 1985-07-22, under 510(k) number K852164.

Who is the listed applicant for CEDIA TOTAL T4 ASSAY?

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

What is the FDA product code for CEDIA TOTAL T4 ASSAY?

The FDA product code for CEDIA TOTAL T4 ASSAY is KLI.

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Other records listing Microgenics 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.

K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSK101754THERMO SCIENTIFIC CEDIA OPIATE OFT 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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