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FDA 510(k)

DADE(R) PLASMINOGEN CHROMOGENIC ASSAY

K-Number: K890409 · 1989-02-27

ApplicantBaxter Healthcare Corp
Decision Date1989-02-27
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE(R) PLASMINOGEN 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 1989-02-27 under 510(k) number K890409. 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(R) PLASMINOGEN CHROMOGENIC ASSAY?

DADE(R) PLASMINOGEN CHROMOGENIC ASSAY is a medical device that received FDA 510(k) clearance on 1989-02-27. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K890409.

When did DADE(R) PLASMINOGEN CHROMOGENIC ASSAY receive FDA 510(k) clearance?

DADE(R) PLASMINOGEN CHROMOGENIC ASSAY received FDA 510(k) clearance on 1989-02-27, under 510(k) number K890409.

Who is the listed applicant for DADE(R) PLASMINOGEN 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(R) PLASMINOGEN CHROMOGENIC ASSAY?

The FDA product code for DADE(R) PLASMINOGEN CHROMOGENIC ASSAY is GGP.

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Related Devices (Code: GGP)

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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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