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FDA 510(k)

COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA

K-Number: K853461 · 1985-08-29

ApplicantAmerican Dade
Decision Date1985-08-29
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1985-08-29 under 510(k) number K853461. 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 COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA?

COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is American Dade. The 510(k) number is K853461.

When did COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA receive FDA 510(k) clearance?

COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA received FDA 510(k) clearance on 1985-08-29, under 510(k) number K853461.

Who is the listed applicant for COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA?

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

What is the FDA product code for COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA?

The FDA product code for COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA is GGP.

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Other records listing American Dade as applicant

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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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