510(k) K896117

MODIFIED MODEL 535(TM) LUMINOMETER by Los Alamos Diagnostics — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1989
Date Received
October 20, 1989
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