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FDA 510(k)

DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO

K-Number: K851127 · 1985-05-29

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1985-05-29
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1985-05-29 under 510(k) number K851127. 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 DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO?

DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K851127.

When did DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO receive FDA 510(k) clearance?

DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO received FDA 510(k) clearance on 1985-05-29, under 510(k) number K851127.

Who is the listed applicant for DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO?

The FDA product code for DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO is JPA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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