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FDA 510(k)

LIDOCAINE ANALYTICAL TEST PACK ACA

K-Number: K833379 · 1983-12-27

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

Device Summary

LIDOCAINE ANALYTICAL TEST PACK ACA 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 K833379. The device is classified under product code KLR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIDOCAINE ANALYTICAL TEST PACK ACA?

LIDOCAINE ANALYTICAL TEST PACK ACA 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 K833379.

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

LIDOCAINE ANALYTICAL TEST PACK ACA received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833379.

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

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 LIDOCAINE ANALYTICAL TEST PACK ACA?

The FDA product code for LIDOCAINE ANALYTICAL TEST PACK ACA is KLR.

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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: KLR)

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.

K090282QMS LIDOCAINEThermo Fisher Scientific, Inc.K033809DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49DDade Behring, Inc.K032334ROCHE ONLINE TDM LIDOCAINERoche Diagnostics Corp.K973102LIDOCAINE EIA ASSAYDiagnostic Reagents, Inc.K881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641Diagnostic SystemsK853010COBAS REAGENT FOR LIDOCAINE & CALIBRATORSRoche Diagnostic Systems, 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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