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FDA 510(k)

GENTAMICIN TEST PACK-ACA

K-Number: K831210 · 1983-05-25

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1983-05-25
Product CodeDJB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN 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 1983-05-25 under 510(k) number K831210. The device is classified under product code DJB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN TEST PACK-ACA?

GENTAMICIN TEST PACK-ACA is a medical device that received FDA 510(k) clearance on 1983-05-25. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K831210.

When did GENTAMICIN TEST PACK-ACA receive FDA 510(k) clearance?

GENTAMICIN TEST PACK-ACA received FDA 510(k) clearance on 1983-05-25, under 510(k) number K831210.

Who is the listed applicant for GENTAMICIN 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 GENTAMICIN TEST PACK-ACA?

The FDA product code for GENTAMICIN TEST PACK-ACA is DJB.

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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: DJB)

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.

K832792AMES TDA SISOMICIN TEST-CONTROL SERUMMiles Laboratories, Inc.K821669AMES TDA GENTAMICIN TESTMiles Laboratories, Inc.K812394MRI GENTAMICIN RIA KITMicroanalytic Research, Inc.K811844COAT-A-COUNT GENTAMICIN RIA KITDiagnostic Products Corp.K800537GAMMA STICK GENTAMICIN RIA KITAlpha Gamma LaboratoryK791770QUANTIMUNE GENTAMICIN RIA GENTAMICINBio-Rad

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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