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FDA 510(k)

EMIT-TFG PRISMA THYROXINE ASSAY

K-Number: K810586 · 1981-03-17

ApplicantSyva Co.
Decision Date1981-03-17
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMIT-TFG PRISMA THYROXINE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1981-03-17 under 510(k) number K810586. 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 EMIT-TFG PRISMA THYROXINE ASSAY?

EMIT-TFG PRISMA THYROXINE ASSAY is a medical device that received FDA 510(k) clearance on 1981-03-17. The listed applicant is Syva Co.. The 510(k) number is K810586.

When did EMIT-TFG PRISMA THYROXINE ASSAY receive FDA 510(k) clearance?

EMIT-TFG PRISMA THYROXINE ASSAY received FDA 510(k) clearance on 1981-03-17, under 510(k) number K810586.

Who is the listed applicant for EMIT-TFG PRISMA THYROXINE ASSAY?

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

What is the FDA product code for EMIT-TFG PRISMA THYROXINE ASSAY?

The FDA product code for EMIT-TFG PRISMA THYROXINE ASSAY is KLI.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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