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FDA 510(k)

AMIKACIN ANALYTICAL TEST PACK ACA

K-Number: K843211 · 1984-09-12

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1984-09-12
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMIKACIN 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 1984-09-12 under 510(k) number K843211. The device is classified under product code KLQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIKACIN ANALYTICAL TEST PACK ACA?

AMIKACIN ANALYTICAL TEST PACK ACA is a medical device that received FDA 510(k) clearance on 1984-09-12. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K843211.

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

AMIKACIN ANALYTICAL TEST PACK ACA received FDA 510(k) clearance on 1984-09-12, under 510(k) number K843211.

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

The FDA product code for AMIKACIN ANALYTICAL TEST PACK ACA is KLQ.

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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: KLQ)

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.

K052815QMS AMIKACIN REAGENTSSeradyn, Inc.K033884RANDOX AMIKACINRandox Laboratories, Ltd.K955570INNOFLUOR AMIKACIN ASSAY SYSTEMOxis Intl., Inc.K903100INNOFLUOR (TM) AMIKACIN REAGENT SETInnotron of Oregon, Inc.K894517FPR AMIKACIN KITColony Laboratories, Inc.K852317COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATORRoche 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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