510(k) K882362

STAT FIX MICROWAVE IRRADIATION MEDIUM by Stat Path — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1988
Date Received
June 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type