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FDA 510(k)

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

K-Number: K072078 · 2007-12-19

ApplicantBiokit, S.A.
Decision Date2007-12-19
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2007-12-19 under 510(k) number K072078. 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 QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307?

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 is a medical device that received FDA 510(k) clearance on 2007-12-19. The listed applicant is Biokit, S.A.. The 510(k) number is K072078.

When did QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 receive FDA 510(k) clearance?

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 received FDA 510(k) clearance on 2007-12-19, under 510(k) number K072078.

Who is the listed applicant for QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307?

The FDA 510(k) record lists Biokit, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307?

The FDA product code for QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 is JZG.

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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 DiagnosticsK063272DIMENSION 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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