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FDA 510(k)

DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD

K-Number: K922701 · 1992-09-09

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1992-09-09
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD 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 1992-09-09 under 510(k) number K922701. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD?

DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD is a medical device that received FDA 510(k) clearance on 1992-09-09. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K922701.

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

DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD received FDA 510(k) clearance on 1992-09-09, under 510(k) number K922701.

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

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 TSH METHOD?

The FDA product code for DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD is JLW.

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

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Related Devices (Code: JLW)

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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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