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FDA 510(k)

ACA GENTAMICIN TEST PACK

K-Number: K852672 · 1985-08-02

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1985-08-02
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACA GENTAMICIN 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 1985-08-02 under 510(k) number K852672. The device is classified under product code LCD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA GENTAMICIN TEST PACK?

ACA GENTAMICIN TEST PACK is a medical device that received FDA 510(k) clearance on 1985-08-02. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K852672.

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

ACA GENTAMICIN TEST PACK received FDA 510(k) clearance on 1985-08-02, under 510(k) number K852672.

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

The FDA product code for ACA GENTAMICIN TEST PACK is LCD.

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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: LCD)

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.

K243500ARCHITECT iGentamicinAbbott LaboratoriesK102699ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSAbbott LaboratoriesK060709MULTIGENT GENTAMICINSeradyn, Inc.K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHEOrtho-Clinical Diagnostics, Inc.K020704ROCHE ONLINE GENTAMICINRoche Diagnostics Corp.K012978RANDOX GENTAMICINRandox Laboratories, Ltd.

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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