DAT — Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code DAT covers "Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 864.7340. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DAT
Device Class
Class II
Regulation Number
864.7340
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K924892organon teknikaFIBRINOSTIKA(R) FGDP MICROELISA SYSTEMApril 21, 1994
K781103medishieldSPECTRASCANSeptember 27, 1978