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FDA 510(k)

AUTOPAK-12 FERRITIN KIT

K-Number: K811808 · 1981-07-10

ApplicantMicromedic Systems
Decision Date1981-07-10
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOPAK-12 FERRITIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811808. 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-12 FERRITIN KIT?

AUTOPAK-12 FERRITIN KIT is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Micromedic Systems. The 510(k) number is K811808.

When did AUTOPAK-12 FERRITIN KIT receive FDA 510(k) clearance?

AUTOPAK-12 FERRITIN KIT received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811808.

Who is the listed applicant for AUTOPAK-12 FERRITIN KIT?

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-12 FERRITIN KIT?

The FDA product code for AUTOPAK-12 FERRITIN KIT 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 KITK871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KITK870904MICROMEDIC 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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