510(k) K921536

ACCULYTE CHEMILUMINESCENCE ANALYZER by Laboratory Technologies, Inc. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1993
Date Received
March 11, 1992
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