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FDA 510(k)

LIATEST(R) AT III TEST KIT

K-Number: K905110 · 1991-01-24

ApplicantAmerican Bioproducts Co.
Decision Date1991-01-24
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LIATEST(R) AT III TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1991-01-24 under 510(k) number K905110. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIATEST(R) AT III TEST KIT?

LIATEST(R) AT III TEST KIT is a medical device that received FDA 510(k) clearance on 1991-01-24. The listed applicant is American Bioproducts Co.. The 510(k) number is K905110.

When did LIATEST(R) AT III TEST KIT receive FDA 510(k) clearance?

LIATEST(R) AT III TEST KIT received FDA 510(k) clearance on 1991-01-24, under 510(k) number K905110.

Who is the listed applicant for LIATEST(R) AT III TEST KIT?

The FDA 510(k) record lists American Bioproducts Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIATEST(R) AT III TEST KIT?

The FDA product code for LIATEST(R) AT III TEST KIT is JBQ.

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Other records listing American Bioproducts Co. 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.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERK971519ASSERACHROM TPA TEST KITK964716STA LIATEST CONTROL [N]+[P] KITK964728STA-LIATEST D-DI TEST KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KIT

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Related Devices (Code: JBQ)

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.

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare DiagnosticsK070301HEMOSIL ANTITHROMBINInstrumentation Laboratory COK062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory COK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen BiomedK033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation Laboratory CO

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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