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FDA 510(k)

DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR

K-Number: K941219 · 1994-08-09

ApplicantDupont Medical Products
Decision Date1994-08-09
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dupont Medical Products. It received FDA 510(k) clearance on 1994-08-09 under 510(k) number K941219. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR?

DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1994-08-09. The listed applicant is Dupont Medical Products. The 510(k) number is K941219.

When did DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR receive FDA 510(k) clearance?

DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR received FDA 510(k) clearance on 1994-08-09, under 510(k) number K941219.

Who is the listed applicant for DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR?

The FDA 510(k) record lists Dupont Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR?

The FDA product code for DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR is JIX.

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Other records listing Dupont Medical Products 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.

K952815DUPONT LIPASE CALIBRATORK950920DUPONT DIMENSION TOTAL PROTEIN METHODK952816LIPASE FLEX REAGENT CARTRIDGEK952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROLK945280DUPONT DIMENSION C-REACTIVE PROTEIN METHODK944932PHENOBARBITAL FLEX REAGENT CARTRIDGE

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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