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FDA 510(k)

AUTOPAK FERRITIN TEST DELIVERY SYS

K-Number: K823275 · 1982-12-03

ApplicantMicromedic Systems
Decision Date1982-12-03
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOPAK FERRITIN TEST DELIVERY SYS is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1982-12-03 under 510(k) number K823275. 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 AUTOPAK FERRITIN TEST DELIVERY SYS?

AUTOPAK FERRITIN TEST DELIVERY SYS is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Micromedic Systems. The 510(k) number is K823275.

When did AUTOPAK FERRITIN TEST DELIVERY SYS receive FDA 510(k) clearance?

AUTOPAK FERRITIN TEST DELIVERY SYS received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823275.

Who is the listed applicant for AUTOPAK FERRITIN TEST DELIVERY SYS?

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

What is the FDA product code for AUTOPAK FERRITIN TEST DELIVERY SYS?

The FDA product code for AUTOPAK FERRITIN TEST DELIVERY SYS is DBF.

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Other records listing Micromedic Systems 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.

K923643MEDICOOLK872309MICROMEDIC COMBOSTAT LH/FSH KITK871008MICROMEDIC NEONATAL T4 KITK870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KITK871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KITK870245AUTOPAK TSH MONOCLONAL IRMA KIT

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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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