510(k) K864201

LAD MODEL 535 LUMINOMETER by Los Alamos Diagnostics — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1987
Date Received
October 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
Submission Type