GTC — Antisera, All Types, Klebsiella Spp. Class I

FDA Device Classification

FDA product code GTC covers "Antisera, All Types, Klebsiella Spp.", a Class I medical device regulated under 21 CFR 866.3340. 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
GTC
Device Class
Class I
Regulation Number
866.3340
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K830276ritmedSECURET DRAPE & INSTRUMENT RETAINER/INCLMarch 29, 1983