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FDA 510(k)

DADE FACTOR IX CHROMOGENIC ASSAY

K-Number: K884551 · 1988-12-30

ApplicantBaxter Healthcare Corp
Decision Date1988-12-30
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE FACTOR IX CHROMOGENIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-12-30 under 510(k) number K884551. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE FACTOR IX CHROMOGENIC ASSAY?

DADE FACTOR IX CHROMOGENIC ASSAY is a medical device that received FDA 510(k) clearance on 1988-12-30. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K884551.

When did DADE FACTOR IX CHROMOGENIC ASSAY receive FDA 510(k) clearance?

DADE FACTOR IX CHROMOGENIC ASSAY received FDA 510(k) clearance on 1988-12-30, under 510(k) number K884551.

Who is the listed applicant for DADE FACTOR IX CHROMOGENIC ASSAY?

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

What is the FDA product code for DADE FACTOR IX CHROMOGENIC ASSAY?

The FDA product code for DADE FACTOR IX CHROMOGENIC ASSAY is GGP.

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Related Devices (Code: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation 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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