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FDA 510(k)

K-ASSAY D-DIMER CONTROLS

K-Number: K012422 · 2001-08-21

ApplicantKamiya Biomedical Co.
Decision Date2001-08-21
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

K-ASSAY D-DIMER CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Co.. It received FDA 510(k) clearance on 2001-08-21 under 510(k) number K012422. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY D-DIMER CONTROLS?

K-ASSAY D-DIMER CONTROLS is a medical device that received FDA 510(k) clearance on 2001-08-21. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K012422.

When did K-ASSAY D-DIMER CONTROLS receive FDA 510(k) clearance?

K-ASSAY D-DIMER CONTROLS received FDA 510(k) clearance on 2001-08-21, under 510(k) number K012422.

Who is the listed applicant for K-ASSAY D-DIMER CONTROLS?

The FDA 510(k) record lists Kamiya Biomedical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-ASSAY D-DIMER CONTROLS?

The FDA product code for K-ASSAY D-DIMER CONTROLS is GGC.

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Other records listing Kamiya Biomedical Co. 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.

K093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLK091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORK050944K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETK042241K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CK030687K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091CK023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

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Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, Inc.

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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