510(k) K961183

CBI 7520 READER by Columbia Bioscience, Inc. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1996
Date Received
March 26, 1996
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