GPN — Antiserum, Typhus Fever Class I

FDA Device Classification

FDA product code GPN covers "Antiserum, Typhus Fever", a Class I medical device regulated under 21 CFR 866.3500. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
GPN
Device Class
Class I
Regulation Number
866.3500
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K864110hillcrest biologicalsRICKETTSIAL IGG AND IGM IFA KITMarch 12, 1987