K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR— 510(k) K992976

Name: FDA 510(k) clearance K992976
Creator: U.S. Food and Drug Administration
Published: 1999-11-01

Substantially Equivalent

Kamiya Biomedical Co.

FDA 510(k) clearance K992976 for K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR, Substantially Equivalent on 1999-11-01. Applicant: Kamiya Biomedical Co.. Device class: 2.

Clearance details

Applicant: Kamiya Biomedical Co.
Product code: Code DDR
Device class: Class 2
Regulation: 21 CFR 866.5680
Advisory panel: Immunology
Date received: 1999-09-03
Decision date: 1999-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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