510(k) K811178

HUMAN IGG-ALBUMIN TEST KIT by Meloy Laboratories, Inc. — Product Code CJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1981
Date Received
April 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radial Immunodiffusion, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type