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FDA 510(k)

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

K-Number: K932980 · 1993-10-18

ApplicantSigma Diagnostics, Inc.
Decision Date1993-10-18
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-10-18 under 510(k) number K932980. 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 TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116?

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 is a medical device that received FDA 510(k) clearance on 1993-10-18. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K932980.

When did TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 receive FDA 510(k) clearance?

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 received FDA 510(k) clearance on 1993-10-18, under 510(k) number K932980.

Who is the listed applicant for TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116?

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

What is the FDA product code for TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116?

The FDA product code for TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 is CDX.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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 LaboratoriesK933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.K931295IQ TT4 ASSAYBecton Dickinson Advanced Diagnostics

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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