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FDA 510(k)

ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR

K-Number: K914225 · 1991-11-22

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1991-11-22
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACA(R) BETA-2-MICROGLOBULIN 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 1991-11-22 under 510(k) number K914225. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR?

ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K914225.

When did ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR receive FDA 510(k) clearance?

ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914225.

Who is the listed applicant for ACA(R) BETA-2-MICROGLOBULIN 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) BETA-2-MICROGLOBULIN CALIBRATOR?

The FDA product code for ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR is JZG.

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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: JZG)

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.

K161297Beta-2-MicroglobulinBeckman Coulter Ireland, Inc.K122066HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K110874ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083289HUMAN BETA-2 MICROGLOBULIN KITThe Binding Site, Ltd.K083463DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL MSiemens Healthcare DiagnosticsK072078QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307Biokit, S.A.

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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