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FDA 510(k)

ENZYMUN-TEST FERRITIN

K-Number: K860137 · 1986-03-28

ApplicantBoehringer Mannheim Corp.
Decision Date1986-03-28
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENZYMUN-TEST FERRITIN is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1986-03-28 under 510(k) number K860137. 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 ENZYMUN-TEST FERRITIN?

ENZYMUN-TEST FERRITIN is a medical device that received FDA 510(k) clearance on 1986-03-28. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K860137.

When did ENZYMUN-TEST FERRITIN receive FDA 510(k) clearance?

ENZYMUN-TEST FERRITIN received FDA 510(k) clearance on 1986-03-28, under 510(k) number K860137.

Who is the listed applicant for ENZYMUN-TEST FERRITIN?

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

What is the FDA product code for ENZYMUN-TEST FERRITIN?

The FDA product code for ENZYMUN-TEST FERRITIN is DBF.

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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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