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FDA 510(k)

QUANTITATIVE FIBRINOGEN ASSAY

K-Number: K963902 · 1996-11-29

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1996-11-29
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUANTITATIVE FIBRINOGEN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1996-11-29 under 510(k) number K963902. The device is classified under product code GIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTITATIVE FIBRINOGEN ASSAY?

QUANTITATIVE FIBRINOGEN ASSAY is a medical device that received FDA 510(k) clearance on 1996-11-29. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K963902.

When did QUANTITATIVE FIBRINOGEN ASSAY receive FDA 510(k) clearance?

QUANTITATIVE FIBRINOGEN ASSAY received FDA 510(k) clearance on 1996-11-29, under 510(k) number K963902.

Who is the listed applicant for QUANTITATIVE FIBRINOGEN ASSAY?

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

What is the FDA product code for QUANTITATIVE FIBRINOGEN ASSAY?

The FDA product code for QUANTITATIVE FIBRINOGEN ASSAY is GIS.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)K951100ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)K950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)

View all 126 devices →

Related Devices (Code: GIS)

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.

K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDiazyme LaboratoriesK042919FIBROTEK FIBR2 Diagnostics, Inc.K993482K-ASSAY FIBRINOGENKamiya Biomedical Co.K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITDiagnostic SpecialtiesK925494BIOMERIEUX HEMOLAB FIBRINOMATBiomerieux Vitek, Inc.K923921IL TEST PT FIBRINOGEN HSInstrumentation Laboratory CO

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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