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FDA 510(k)

DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD

K-Number: K904304 · 1990-10-26

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1990-10-26
Product CodeKLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD 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 1990-10-26 under 510(k) number K904304. The device is classified under product code KLB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD?

DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD is a medical device that received FDA 510(k) clearance on 1990-10-26. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K904304.

When did DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD receive FDA 510(k) clearance?

DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD received FDA 510(k) clearance on 1990-10-26, under 510(k) number K904304.

Who is the listed applicant for DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD?

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 DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD?

The FDA product code for DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD is KLB.

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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: KLB)

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.

K060853ONLINE TDM TOBRAMYCINRoche Diagnostics Corp.K012312IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)Diagnostic Products Corp.K003341EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORSSyva Co., Dade Behring, Inc.K903192IL TOBRAMYCIN ASSAYInstrumentation Laboratory COK893913TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHODTechnicon Instruments Corp.K882294EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAYSyva Co.

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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