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FDA 510(k)

COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS

K-Number: K870107 · 1987-02-10

ApplicantDiagnostic Products Corp.
Decision Date1987-02-10
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1987-02-10 under 510(k) number K870107. 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 COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS?

COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS is a medical device that received FDA 510(k) clearance on 1987-02-10. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K870107.

When did COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS receive FDA 510(k) clearance?

COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS received FDA 510(k) clearance on 1987-02-10, under 510(k) number K870107.

Who is the listed applicant for COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS?

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

What is the FDA product code for COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS?

The FDA product code for COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS is DBF.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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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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