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FDA 510(k)

NORDICLAB FERRITIN IRMA TEST

K-Number: K801989 · 1980-09-16

ApplicantNordiclab Intl.
Decision Date1980-09-16
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NORDICLAB FERRITIN IRMA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Nordiclab Intl.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801989. 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 NORDICLAB FERRITIN IRMA TEST?

NORDICLAB FERRITIN IRMA TEST is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Nordiclab Intl.. The 510(k) number is K801989.

When did NORDICLAB FERRITIN IRMA TEST receive FDA 510(k) clearance?

NORDICLAB FERRITIN IRMA TEST received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801989.

Who is the listed applicant for NORDICLAB FERRITIN IRMA TEST?

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

What is the FDA product code for NORDICLAB FERRITIN IRMA TEST?

The FDA product code for NORDICLAB FERRITIN IRMA TEST is DBF.

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Other records listing Nordiclab Intl. 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.

K801988NORDICLAB PROSTATIC ACID PHOSPHATASE RIAK800920NORDICLAB ESTRADIOL RIA TESTK800922NORDICLAB PROGESTERONE RIA TESTK800921NORDICLAB TESTOSTERONE RIA TESTK792189NORDICLAB TOTAL ESTRIOL RIA TESTK782157IRMA TEST, NORDICLAB FERRITIN

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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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