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FDA 510(k)

IQ TUPTAKE ASSAY

K-Number: K931294 · 1993-07-22

ApplicantBecton Dickinson Advanced Diagnostics
Decision Date1993-07-22
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IQ TUPTAKE 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 1993-07-22 under 510(k) number K931294. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQ TUPTAKE ASSAY?

IQ TUPTAKE ASSAY is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Becton Dickinson Advanced Diagnostics. The 510(k) number is K931294.

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

IQ TUPTAKE ASSAY received FDA 510(k) clearance on 1993-07-22, under 510(k) number K931294.

Who is the listed applicant for IQ TUPTAKE 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 TUPTAKE ASSAY?

The FDA product code for IQ TUPTAKE ASSAY is KHQ.

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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) STREPK931295IQ TT4 ASSAYK926356PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREGK925132BECTON DICKINSON THYROID STIMULATING HORMONE SYSTEK923673PRECISE STREP AK923060IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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