510(k) K811680

ACCUDEX by Biodynamics Corp. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1981
Date Received
June 15, 1981
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