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FDA 510(k)

RABBIT ANTI-HUMAN ANTITHROMBIN III

K-Number: K832268 · 1983-08-12

ApplicantGelco Diagnostics, Inc.
Decision Date1983-08-12
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RABBIT ANTI-HUMAN ANTITHROMBIN III is the device name listed in this FDA 510(k) record. The listed applicant is Gelco Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832268. 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 RABBIT ANTI-HUMAN ANTITHROMBIN III?

RABBIT ANTI-HUMAN ANTITHROMBIN III is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Gelco Diagnostics, Inc.. The 510(k) number is K832268.

When did RABBIT ANTI-HUMAN ANTITHROMBIN III receive FDA 510(k) clearance?

RABBIT ANTI-HUMAN ANTITHROMBIN III received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832268.

Who is the listed applicant for RABBIT ANTI-HUMAN ANTITHROMBIN III?

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

What is the FDA product code for RABBIT ANTI-HUMAN ANTITHROMBIN III?

The FDA product code for RABBIT ANTI-HUMAN ANTITHROMBIN III is JBQ.

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Other records listing Gelco 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.

K832256GOAT ANTI-HUMAN IMMUNOGLOBULINS-K832266FITC GOAT ANTI-HUMAN KAPPA AFFINITYK832265FITC GOAT ANTI-HUMAN IGM H CHAINK832260GOAT ANTI-HUMAN KAPPA AFFINITYK832258GOAT ANTI-HUMAN IGG Y CHAIN SPECIFICK832263FITC GOAT ANTI-HUMAN IGA A CHAIN

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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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