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FDA 510(k)

QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(

K-Number: K964767 · 1997-05-29

ApplicantR&D Systems, Inc.
Decision Date1997-05-29
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1997-05-29 under 510(k) number K964767. 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 QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(?

QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( is a medical device that received FDA 510(k) clearance on 1997-05-29. The listed applicant is R&D Systems, Inc.. The 510(k) number is K964767.

When did QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( receive FDA 510(k) clearance?

QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( received FDA 510(k) clearance on 1997-05-29, under 510(k) number K964767.

Who is the listed applicant for QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(?

The FDA product code for QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( is JZG.

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Other records listing R&D Systems, Inc. as applicant

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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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