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FDA 510(k)

DSL BETA 2 MICROGLOBULIN (DSL 6100)

K-Number: K912173 · 1991-08-13

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1991-08-13
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DSL BETA 2 MICROGLOBULIN (DSL 6100) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1991-08-13 under 510(k) number K912173. 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 DSL BETA 2 MICROGLOBULIN (DSL 6100)?

DSL BETA 2 MICROGLOBULIN (DSL 6100) is a medical device that received FDA 510(k) clearance on 1991-08-13. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K912173.

When did DSL BETA 2 MICROGLOBULIN (DSL 6100) receive FDA 510(k) clearance?

DSL BETA 2 MICROGLOBULIN (DSL 6100) received FDA 510(k) clearance on 1991-08-13, under 510(k) number K912173.

Who is the listed applicant for DSL BETA 2 MICROGLOBULIN (DSL 6100)?

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

What is the FDA product code for DSL BETA 2 MICROGLOBULIN (DSL 6100)?

The FDA product code for DSL BETA 2 MICROGLOBULIN (DSL 6100) 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 Diagnostic Systems Laboratories, 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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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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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