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FDA 510(k)

T-UPTAKE EIA TEST

K-Number: K951586 · 1995-05-15

ApplicantDiagnostic Reagents, Inc.
Decision Date1995-05-15
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T-UPTAKE EIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K951586. 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 T-UPTAKE EIA TEST?

T-UPTAKE EIA TEST is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K951586.

When did T-UPTAKE EIA TEST receive FDA 510(k) clearance?

T-UPTAKE EIA TEST received FDA 510(k) clearance on 1995-05-15, under 510(k) number K951586.

Who is the listed applicant for T-UPTAKE EIA TEST?

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

What is the FDA product code for T-UPTAKE EIA TEST?

The FDA product code for T-UPTAKE EIA TEST is KHQ.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA 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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