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FDA 510(k)

PHADECODE XA INHIBITOR ASSAY

K-Number: K792019 · 1979-11-05

ApplicantPharmaseal Div., Baxter Healthcare Corp.
Decision Date1979-11-05
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PHADECODE XA INHIBITOR ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K792019. 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 PHADECODE XA INHIBITOR ASSAY?

PHADECODE XA INHIBITOR ASSAY is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. The 510(k) number is K792019.

When did PHADECODE XA INHIBITOR ASSAY receive FDA 510(k) clearance?

PHADECODE XA INHIBITOR ASSAY received FDA 510(k) clearance on 1979-11-05, under 510(k) number K792019.

Who is the listed applicant for PHADECODE XA INHIBITOR ASSAY?

The FDA 510(k) record lists Pharmaseal Div., Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHADECODE XA INHIBITOR ASSAY?

The FDA product code for PHADECODE XA INHIBITOR ASSAY is JBQ.

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Other records listing Pharmaseal Div., Baxter Healthcare Corp. 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.

K792369HYPERALIMENTATION DRESSING TRAYK792141CONTINUOUS FLUSH DEVICEK791773VENTILATOR TUBE WITH FILTERK791156AMIPAQUE MYELOGRAM TRAYK790896TWO-WAY ANESTHESIA FILTERK790409LOW DEAD SPACE INSULIN SYRINGE

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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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