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FDA 510(k)

FIBRINOSTICON

K-Number: K880077 · 1988-02-09

ApplicantOrganon Teknika Corp.
Decision Date1988-02-09
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRINOSTICON is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1988-02-09 under 510(k) number K880077. The device is classified under product code GHH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOSTICON?

FIBRINOSTICON is a medical device that received FDA 510(k) clearance on 1988-02-09. The listed applicant is Organon Teknika Corp.. The 510(k) number is K880077.

When did FIBRINOSTICON receive FDA 510(k) clearance?

FIBRINOSTICON received FDA 510(k) clearance on 1988-02-09, under 510(k) number K880077.

Who is the listed applicant for FIBRINOSTICON?

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

What is the FDA product code for FIBRINOSTICON?

The FDA product code for FIBRINOSTICON is GHH.

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Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: GHH)

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.

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme LaboratoriesK072288PATHFAST D-DIMERMitsubishi Kagaku IatronK070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOlympus Life & Material Science Europa GmbH (IrishK062203TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K042890TRIAGE D-DIMER TEST, MODEL 98100Biosite IncorporatedK030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.

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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