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FDA 510(k)

IQ TT4 ASSAY

K-Number: K931295 · 1993-07-20

ApplicantBecton Dickinson Advanced Diagnostics
Decision Date1993-07-20
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IQ TT4 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Advanced Diagnostics. It received FDA 510(k) clearance on 1993-07-20 under 510(k) number K931295. 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 IQ TT4 ASSAY?

IQ TT4 ASSAY is a medical device that received FDA 510(k) clearance on 1993-07-20. The listed applicant is Becton Dickinson Advanced Diagnostics. The 510(k) number is K931295.

When did IQ TT4 ASSAY receive FDA 510(k) clearance?

IQ TT4 ASSAY received FDA 510(k) clearance on 1993-07-20, under 510(k) number K931295.

Who is the listed applicant for IQ TT4 ASSAY?

The FDA 510(k) record lists Becton Dickinson Advanced Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IQ TT4 ASSAY?

The FDA product code for IQ TT4 ASSAY is CDX.

Related Clinical Trials

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.

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Other records listing Becton Dickinson Advanced Diagnostics 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.

K935667QTEST(R) STREPK931294IQ TUPTAKE ASSAYK926356PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREGK925132BECTON DICKINSON THYROID STIMULATING HORMONE SYSTEK923673PRECISE STREP AK923060IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY

View all 10 devices →

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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