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FDA 510(k)

ACA ACETAMINOPHEN ANALYTICAL TEST PACK

K-Number: K842548 · 1984-08-16

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1984-08-16
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACA ACETAMINOPHEN ANALYTICAL TEST PACK 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 1984-08-16 under 510(k) number K842548. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA ACETAMINOPHEN ANALYTICAL TEST PACK?

ACA ACETAMINOPHEN ANALYTICAL TEST PACK is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K842548.

When did ACA ACETAMINOPHEN ANALYTICAL TEST PACK receive FDA 510(k) clearance?

ACA ACETAMINOPHEN ANALYTICAL TEST PACK received FDA 510(k) clearance on 1984-08-16, under 510(k) number K842548.

Who is the listed applicant for ACA ACETAMINOPHEN ANALYTICAL TEST PACK?

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 ACA ACETAMINOPHEN ANALYTICAL TEST PACK?

The FDA product code for ACA ACETAMINOPHEN ANALYTICAL TEST PACK is LDP.

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Other records listing E.I. Dupont DE Nemours & Co., 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: LDP)

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.

K261364Atellica CH Acetaminophen 2 (ACTM)Siemens Healthcare Diagnostics, Inc.K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc.K110726ROCHE ACETAMINOPHEN ASSAYRoche DiagnosticsK100200ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138Siemens Healthcare DiagnosticsK081938ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30Genzyme Diagnostics P.E.I., Inc.

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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