DCH — System, Test, C-Reactive Protein, Rhodamine Class II

FDA Device Classification

FDA product code DCH covers "System, Test, C-Reactive Protein, Rhodamine", a Class II medical device regulated under 21 CFR 866.5270. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
DCH
Device Class
Class II
Regulation Number
866.5270
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K964687behring diagnosticsN LATEX CRP MONO REAGENTDecember 16, 1996