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FDA 510(k)

K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT

K-Number: K002948 · 2001-05-18

ApplicantKamiya Biomedical Co.
Decision Date2001-05-18
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT 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 2001-05-18 under 510(k) number K002948. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT?

K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K002948.

When did K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT receive FDA 510(k) clearance?

K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT received FDA 510(k) clearance on 2001-05-18, under 510(k) number K002948.

Who is the listed applicant for K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT?

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 WITH CALIBRATOR SET AND CALIBRATOR DILUENT?

The FDA product code for K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT is DAP.

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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: DAP)

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.

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbHK172903HemosIL D-Dimer HS 500Instrumentation Laboratory COK162227STA® - Liatest® D-DiDiagnostica StagoK160885HemosIL D-Dimer HSInstrumentation Laboratory COK112818VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare 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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