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FDA 510(k)

PROCAINAMIDE ANALYTICAL TEST PACK

K-Number: K833384 · 1983-12-27

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

Device Summary

PROCAINAMIDE 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 1983-12-27 under 510(k) number K833384. The device is classified under product code LAR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCAINAMIDE ANALYTICAL TEST PACK?

PROCAINAMIDE ANALYTICAL TEST PACK 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 K833384.

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

PROCAINAMIDE ANALYTICAL TEST PACK received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833384.

Who is the listed applicant for PROCAINAMIDE 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 PROCAINAMIDE ANALYTICAL TEST PACK?

The FDA product code for PROCAINAMIDE ANALYTICAL TEST PACK is LAR.

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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

View all 253 devices →

Related Devices (Code: LAR)

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.

K060773ONLINE TDM PROCAINAMIDERoche Diagnostics Corp.K032573DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110Dade Behring, Inc.K010812EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229Syva Co., Dade Behring, Inc.K971716PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K963306CEDIA N-ACETYLPROCAINAMIDE ASSAYBoehringer Mannheim Corp.K962099CEDIA PROCAINAMIDE ASSAYBoehringer Mannheim Corp.

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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