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FDA 510(k)

DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI

K-Number: K933188 · 1993-09-22

ApplicantBaxter Diagnostics, Inc.
Decision Date1993-09-22
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI 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 1993-09-22 under 510(k) number K933188. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI?

DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI is a medical device that received FDA 510(k) clearance on 1993-09-22. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K933188.

When did DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI receive FDA 510(k) clearance?

DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI received FDA 510(k) clearance on 1993-09-22, under 510(k) number K933188.

Who is the listed applicant for DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI?

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 (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI?

The FDA product code for DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI is JPA.

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Other records listing Baxter Diagnostics, Inc. 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.

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Related Devices (Code: JPA)

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.

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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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