K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C— 510(k) K042241

Substantially Equivalent

Kamiya Biomedical Co.

FDA 510(k) clearance K042241 for K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C, Substantially Equivalent on 2004-12-10. Applicant: Kamiya Biomedical Co..

Clearance details

Applicant: Kamiya Biomedical Co.
Product code: Code DGC
Advisory panel: Immunology
Date received: 2004-08-19
Decision date: 2004-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tukwila, WA, US

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