GRY — Antigens, All, Leptospira Spp. Class II

FDA Device Classification

Classification Details

Product Code
GRY
Device Class
Class II
Regulation Number
866.3350
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K002024panbioPANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODINovember 22, 2000
K880417hillcrest biologicalsLEPTOSPIROSIS IHAApril 12, 1988