KSF · Class II · 21 CFR 864.9650

FDA Product Code KSF: Kit, Quality Control For Blood Banking Reagents

Leading manufacturers include Ortho Diagnostics, Inc., Dade, Baxter Travenol Diagnostics, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

12
Total
12
Cleared
47d
Avg days
1977
Since

FDA 510(k) Cleared Kit, Quality Control For Blood Banking Reagents Devices (Product Code KSF)

12 devices
1–12 of 12
Cleared Oct 23, 1981
AVI-D CONTROL
K811713
Ortho Diagnostic Systems, Inc.
Hematology · 128d
Cleared Mar 31, 1981
DADE RH CONTROL REAGENT
K810599
American Dade
Hematology · 25d
Cleared Mar 05, 1980
ORTHO ANTISERA CONTROL
K800310
Ortho Diagnostics, Inc.
Hematology · 22d
Cleared May 16, 1979
TEST CELLS
K790249
Hyland Therapeutic Div., Travenol Laboratories
Hematology · 97d
Cleared Jan 17, 1979
COUNTER CHECK, H001, H002, H003
K790025
Diagnostic Technology, Inc.
Hematology · 14d
Cleared Apr 24, 1978
QUALITY CONTROL SYSTEM, SPECTRA
K780097
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 95d
Cleared Nov 07, 1977
REAGENT CONFIDENCE SERA
K771814
Ortho Diagnostics, Inc.
Hematology · 41d
Cleared Jan 25, 1977
UNIVAL CONTROL CELLS
K761284
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 36d

About Product Code KSF - Regulatory Context