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FDA 510(k)

EMIT CENTRIFICHEM THYROXINE ASSAY

K-Number: K772170 · 1977-12-22

ApplicantSyva Co.
Decision Date1977-12-22
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMIT CENTRIFICHEM 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 1977-12-22 under 510(k) number K772170. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT CENTRIFICHEM THYROXINE ASSAY?

EMIT CENTRIFICHEM THYROXINE ASSAY is a medical device that received FDA 510(k) clearance on 1977-12-22. The listed applicant is Syva Co.. The 510(k) number is K772170.

When did EMIT CENTRIFICHEM THYROXINE ASSAY receive FDA 510(k) clearance?

EMIT CENTRIFICHEM THYROXINE ASSAY received FDA 510(k) clearance on 1977-12-22, under 510(k) number K772170.

Who is the listed applicant for EMIT CENTRIFICHEM 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 CENTRIFICHEM THYROXINE ASSAY?

The FDA product code for EMIT CENTRIFICHEM THYROXINE ASSAY is CDX.

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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: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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