GSN — Antiserum, Positive And Negative Febrile Antigen Control Serum Class II

FDA Device Classification

Classification Details

Product Code
GSN
Device Class
Class II
Regulation Number
866.3085
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K952145sa scientificSAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUMJuly 18, 1995
K885113investigacion farmaceutica s.a. de c.vIFA* POSITIVE AND NEGATIVE ANTIGENS CONTROLAugust 15, 1989
K791385immuno-mycologicsNEGATIVE CONTROL SERUM FOR CF RO IDAugust 16, 1979