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FDA 510(k)

GENTAMICIN CALIBRATOR -ACA

K-Number: K831209 · 1983-05-16

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1983-05-16
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN CALIBRATOR -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 1983-05-16 under 510(k) number K831209. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTAMICIN CALIBRATOR -ACA?

GENTAMICIN CALIBRATOR -ACA is a medical device that received FDA 510(k) clearance on 1983-05-16. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K831209.

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

GENTAMICIN CALIBRATOR -ACA received FDA 510(k) clearance on 1983-05-16, under 510(k) number K831209.

Who is the listed applicant for GENTAMICIN CALIBRATOR -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 CALIBRATOR -ACA?

The FDA product code for GENTAMICIN CALIBRATOR -ACA is DLJ.

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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: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, 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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