IFT — Glutaraldehyde Class I

FDA Device Classification

FDA product code IFT covers "Glutaraldehyde", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
IFT
Device Class
Class I
Regulation Number
864.4010
Submission Type
Review Panel
PA
Medical Specialty
Pathology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K940768chimera research and chemicalAD PERFECTFebruary 17, 1995