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FDA 510(k)

DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY

K-Number: K914818 · 1992-01-15

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-01-15
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-01-15 under 510(k) number K914818. 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) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY?

DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY is a medical device that received FDA 510(k) clearance on 1992-01-15. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K914818.

When did DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY receive FDA 510(k) clearance?

DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY received FDA 510(k) clearance on 1992-01-15, under 510(k) number K914818.

Who is the listed applicant for DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY?

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

What is the FDA product code for DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY?

The FDA product code for DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY is 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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