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FDA 510(k)

DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368

K-Number: K032692 · 2004-01-22

ApplicantDako A/S
Decision Date2004-01-22
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 is the device name listed in this FDA 510(k) record. The listed applicant is Dako A/S. It received FDA 510(k) clearance on 2004-01-22 under 510(k) number K032692. 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 DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368?

DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 is a medical device that received FDA 510(k) clearance on 2004-01-22. The listed applicant is Dako A/S. The 510(k) number is K032692.

When did DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 receive FDA 510(k) clearance?

DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 received FDA 510(k) clearance on 2004-01-22, under 510(k) number K032692.

Who is the listed applicant for DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368?

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

What is the FDA product code for DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368?

The FDA product code for DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 is JZG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dako A/S 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.

K041627CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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