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FDA 510(k)

ANTITHROMBIN III ASSAY

K-Number: K781480 · 1978-11-08

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1978-11-08
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ANTITHROMBIN III ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1978-11-08 under 510(k) number K781480. 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 ANTITHROMBIN III ASSAY?

ANTITHROMBIN III ASSAY is a medical device that received FDA 510(k) clearance on 1978-11-08. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K781480.

When did ANTITHROMBIN III ASSAY receive FDA 510(k) clearance?

ANTITHROMBIN III ASSAY received FDA 510(k) clearance on 1978-11-08, under 510(k) number K781480.

Who is the listed applicant for ANTITHROMBIN III ASSAY?

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

What is the FDA product code for ANTITHROMBIN III ASSAY?

The FDA product code for ANTITHROMBIN III ASSAY is JBQ.

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Other records listing Dade, Baxter Travenol Diagnostics, Inc. as applicant

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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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