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Device Classification
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DAT — Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
Class II
FDA Device Classification
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-Number
Applicant
Device Name
Date
K924892
organon teknika
FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
April 21, 1994
K781103
medishield
SPECTRASCAN
September 27, 1978