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FDA 510(k)

PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY

K-Number: K770942 · 1977-07-21

ApplicantPharmaseal Div., Baxter Healthcare Corp.
Decision Date1977-07-21
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PHADECODE DIFFERENTIAL FACTOR XA1 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 1977-07-21 under 510(k) number K770942. 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 DIFFERENTIAL FACTOR XA1 ASSAY?

PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY is a medical device that received FDA 510(k) clearance on 1977-07-21. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. The 510(k) number is K770942.

When did PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY receive FDA 510(k) clearance?

PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY received FDA 510(k) clearance on 1977-07-21, under 510(k) number K770942.

Who is the listed applicant for PHADECODE DIFFERENTIAL FACTOR XA1 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 DIFFERENTIAL FACTOR XA1 ASSAY?

The FDA product code for PHADECODE DIFFERENTIAL FACTOR XA1 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 DEVICEK792019PHADECODE XA INHIBITOR ASSAYK791773VENTILATOR TUBE WITH FILTERK791156AMIPAQUE MYELOGRAM TRAYK790896TWO-WAY ANESTHESIA FILTER

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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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