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FDA 510(k)

SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY

K-Number: K970612 · 1997-06-24

ApplicantSealite Sciences, Inc.
Decision Date1997-06-24
Product CodeDBF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Sealite Sciences, Inc.. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K970612. 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 SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY?

SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K970612.

When did SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY receive FDA 510(k) clearance?

SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY received FDA 510(k) clearance on 1997-06-24, under 510(k) number K970612.

Who is the listed applicant for SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY?

The FDA 510(k) record lists Sealite Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY?

The FDA product code for SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY is DBF.

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Other records listing Sealite Sciences, Inc. 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.

K974551SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAYK972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYK970483AQUALITE INTACT PTHK970188SEALITE SCIENCES, INC. AQUALITE PROLACTINK970085SEALITE SCIENCES AQUALITE FSHK964925SEALITE SCIENCES, INC. AQUALITE LH

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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