510(k) K842313

ELVI 146 SEROSCAN by Logos Scientific, Inc. — Product Code JQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1984
Date Received
June 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class
Class I
Regulation Number
862.2400
Review Panel
CH
Submission Type