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FDA 510(k)

DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT

K-Number: K922680 · 1992-08-20

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1992-08-20
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT 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 1992-08-20 under 510(k) number K922680. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT?

DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT is a medical device that received FDA 510(k) clearance on 1992-08-20. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K922680.

When did DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT receive FDA 510(k) clearance?

DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT received FDA 510(k) clearance on 1992-08-20, under 510(k) number K922680.

Who is the listed applicant for DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT?

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 DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT?

The FDA product code for DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT is JJE.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. as applicant

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Related Devices (Code: JJE)

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

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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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