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FDA 510(k)

DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM

K-Number: K871489 · 1987-06-12

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1987-06-12
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM 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 1987-06-12 under 510(k) number K871489. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM?

DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM is a medical device that received FDA 510(k) clearance on 1987-06-12. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K871489.

When did DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM receive FDA 510(k) clearance?

DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM received FDA 510(k) clearance on 1987-06-12, under 510(k) number K871489.

Who is the listed applicant for DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM?

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 5400 ACTIVE (TM) FERRITIN EIA SYSTEM?

The FDA product code for DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM is DBF.

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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: DBF)

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.

K193650LIAISON FerritinDiaSorin, Inc.K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SASK171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc.K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORKamiya Biomedical CompanyK110736ADVIA CHEMISTRY FERRITIN (FRT) METHODSiemens Healthcare Diagnostics, Inc.K100538TINA-QUANT FERRITIN GEN. 4Roche Diagnostics

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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