DDQ — Antigen, Antiserum, Control, Antithrombin Iii Class II

FDA Device Classification

Classification Details

Product Code
DDQ
Device Class
Class II
Regulation Number
864.7060
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K972257crestat diagnosticsN-ASSAY TIA ANTITHROMBIN III TEST KITOctober 20, 1997
K935307baxter diagnosticsDADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISANovember 22, 1994
K932713trace scientificTRACE TRANSFERRIN REAGENTSeptember 30, 1993
K780012ria diagnosticsANTITHROMBIN III RIAJanuary 20, 1978