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FDA 510(k)

ACA (R) DIGITOXIN CALIBRATOR

K-Number: K891093 · 1989-04-26

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1989-04-26
Product CodeDCJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACA (R) DIGITOXIN CALIBRATOR 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 1989-04-26 under 510(k) number K891093. The device is classified under product code DCJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA (R) DIGITOXIN CALIBRATOR?

ACA (R) DIGITOXIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K891093.

When did ACA (R) DIGITOXIN CALIBRATOR receive FDA 510(k) clearance?

ACA (R) DIGITOXIN CALIBRATOR received FDA 510(k) clearance on 1989-04-26, under 510(k) number K891093.

Who is the listed applicant for ACA (R) DIGITOXIN CALIBRATOR?

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 (R) DIGITOXIN CALIBRATOR?

The FDA product code for ACA (R) DIGITOXIN CALIBRATOR is DCJ.

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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 →

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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