510(k) K810394

PRE-VAP CAPS by Sherman Boosalis — Product Code JJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1981
Date Received
February 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device Class
Class I
Regulation Number
862.2150
Review Panel
CH
Submission Type