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FDA 510(k)

T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT

K-Number: K896925 · 1990-01-18

ApplicantIn Vitro Diagnostics, Inc.
Decision Date1990-01-18
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT is the device name listed in this FDA 510(k) record. The listed applicant is In Vitro Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-01-18 under 510(k) number K896925. 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 ENZYME IMMUNOASSAY CRIMPED TUBE KIT?

T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT is a medical device that received FDA 510(k) clearance on 1990-01-18. The listed applicant is In Vitro Diagnostics, Inc.. The 510(k) number is K896925.

When did T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT receive FDA 510(k) clearance?

T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT received FDA 510(k) clearance on 1990-01-18, under 510(k) number K896925.

Who is the listed applicant for T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT?

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

What is the FDA product code for T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT?

The FDA product code for T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT is KHQ.

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Other records listing In Vitro 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.

K896867THYROID STIMULATING HORMONE-EIA-XTK896863DIGOXIN-EIA-XTK896866LUTEINIZING HORMONE-EIA-XTK896865VITRO T4-EIA-XTK896864FOLLICLE STIMULATING HORMONE-EIA-XTK873832REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801

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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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