GPG — Antigen, Latex Agglutination, Trichinella Spiralis Class I

FDA Device Classification

FDA product code GPG covers "Antigen, Latex Agglutination, Trichinella Spiralis", a Class I medical device regulated under 21 CFR 866.3850. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GPG
Device Class
Class I
Regulation Number
866.3850
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K904613lmd laboratoriesTRICHINELLA SEROLOGY MICROTITER ELISAMarch 21, 1991
K882149utah bioresearchMINIFUGE, MODEL 70July 1, 1988