N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET— 510(k) K964418

Name: FDA 510(k) clearance K964418
Creator: U.S. Food and Drug Administration
Published: 1996-12-13

Substantially Equivalent

Kamiya Technology Services

FDA 510(k) clearance K964418 for N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET, Substantially Equivalent on 1996-12-13. Applicant: Kamiya Technology Services. Device class: 2.

Clearance details

Applicant: Kamiya Technology Services
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1996-10-01
Decision date: 1996-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westport, CT, US

Download summary PDF View on FDA.gov ↗

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