Home / Device Classification / GIT

GIT — Reagent & Control, Partial Thromboplastin Time Class II

FDA Device Classification

Classification Details

Product Code
GIT
Device Class
Class II
Regulation Number
864.7925
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K890051biotrackBIOTRACK APTT CONTROLSFebruary 23, 1989
K881999organon teknikaPLATELIN(R) EXCEL LAugust 17, 1988
K880711creative laboratory productsCLP 0.02 M CALCIUM CHLORIDE SOLUTION.March 18, 1988
K820450pacific hemostasisTHROMBOSCREENMarch 26, 1982