510(k) K904613

TRICHINELLA SEROLOGY MICROTITER ELISA by Lmd Laboratories — Product Code GPG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1991
Date Received
October 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Latex Agglutination, Trichinella Spiralis
Device Class
Class I
Regulation Number
866.3850
Review Panel
MI
Submission Type