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FDA 510(k)

COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY

K-Number: K952515 · 1996-01-23

ApplicantChromogenix AB
Decision Date1996-01-23
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Chromogenix AB. It received FDA 510(k) clearance on 1996-01-23 under 510(k) number K952515. 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 COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY?

COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY is a medical device that received FDA 510(k) clearance on 1996-01-23. The listed applicant is Chromogenix AB. The 510(k) number is K952515.

When did COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY receive FDA 510(k) clearance?

COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY received FDA 510(k) clearance on 1996-01-23, under 510(k) number K952515.

Who is the listed applicant for COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY?

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

What is the FDA product code for COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY?

The FDA product code for COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY is JBQ.

Related Clinical Trials

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.

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Other records listing Chromogenix AB 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.

K963111COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SK952514COACUTE HEPARINK922201COAMATE PROTEIN C CHROMOGENIC ASSAY

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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