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FDA 510(k)

N-ACETYLPROCAINAMIDE ACA-ANALYTICAL

K-Number: K833378 · 1983-12-27

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1983-12-27
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

N-ACETYLPROCAINAMIDE ACA-ANALYTICAL 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 1983-12-27 under 510(k) number K833378. The device is classified under product code LAN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N-ACETYLPROCAINAMIDE ACA-ANALYTICAL?

N-ACETYLPROCAINAMIDE ACA-ANALYTICAL is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K833378.

When did N-ACETYLPROCAINAMIDE ACA-ANALYTICAL receive FDA 510(k) clearance?

N-ACETYLPROCAINAMIDE ACA-ANALYTICAL received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833378.

Who is the listed applicant for N-ACETYLPROCAINAMIDE ACA-ANALYTICAL?

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 N-ACETYLPROCAINAMIDE ACA-ANALYTICAL?

The FDA product code for N-ACETYLPROCAINAMIDE ACA-ANALYTICAL is LAN.

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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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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Related Devices (Code: LAN)

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.

K060738TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.K032564DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.K983812NAPA EIA ASSAYDiagnostic Reagents, Inc.K971713N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K955422AXSYM N-ACETYLPROCAINAMIDEAbbott Laboratories

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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