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FDA 510(k)

DIAG. KIT FOR TOTAL ANTITHROMBIN III

K-Number: K771669 · 1977-11-09

ApplicantAbbott Laboratories
Decision Date1977-11-09
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIAG. KIT FOR TOTAL ANTITHROMBIN III is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1977-11-09 under 510(k) number K771669. 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 DIAG. KIT FOR TOTAL ANTITHROMBIN III?

DIAG. KIT FOR TOTAL ANTITHROMBIN III is a medical device that received FDA 510(k) clearance on 1977-11-09. The listed applicant is Abbott Laboratories. The 510(k) number is K771669.

When did DIAG. KIT FOR TOTAL ANTITHROMBIN III receive FDA 510(k) clearance?

DIAG. KIT FOR TOTAL ANTITHROMBIN III received FDA 510(k) clearance on 1977-11-09, under 510(k) number K771669.

Who is the listed applicant for DIAG. KIT FOR TOTAL ANTITHROMBIN III?

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

What is the FDA product code for DIAG. KIT FOR TOTAL ANTITHROMBIN III?

The FDA product code for DIAG. KIT FOR TOTAL ANTITHROMBIN III is JBQ.

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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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