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FDA 510(k)

HUMAN BETA-2 MICROGLOBULIN KIT

K-Number: K083289 · 2009-05-06

ApplicantThe Binding Site, Ltd.
Decision Date2009-05-06
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN BETA-2 MICROGLOBULIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 2009-05-06 under 510(k) number K083289. 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 HUMAN BETA-2 MICROGLOBULIN KIT?

HUMAN BETA-2 MICROGLOBULIN KIT is a medical device that received FDA 510(k) clearance on 2009-05-06. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K083289.

When did HUMAN BETA-2 MICROGLOBULIN KIT receive FDA 510(k) clearance?

HUMAN BETA-2 MICROGLOBULIN KIT received FDA 510(k) clearance on 2009-05-06, under 510(k) number K083289.

Who is the listed applicant for HUMAN BETA-2 MICROGLOBULIN KIT?

The FDA 510(k) record lists The Binding Site, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAN BETA-2 MICROGLOBULIN KIT?

The FDA product code for HUMAN BETA-2 MICROGLOBULIN KIT is JZG.

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Other records listing The Binding Site, Ltd. 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.

K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitK090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZERK081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUSK081674BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)K080384HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER

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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.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.K063272DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGHDade 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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