510(k) K810105

BCA 1000 by Biodynamics Corp. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1981
Date Received
January 16, 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