KSX · Class II · 21 CFR 864.9160

FDA Product Code KSX: Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use

Leading manufacturers include Ortho Diagnostics, Inc., Gamma Biologicals, Inc. and Travenol Laboratories, S.A..

8
Total
8
Cleared
49d
Avg days
1977
Since

FDA 510(k) Cleared Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use Devices (Product Code KSX)

8 devices
1–8 of 8
Cleared Nov 12, 1980
GAMMA LEWIS BLOOD GROUP SUBSTANCE
K802533
Gamma Biologicals, Inc.
Hematology · 28d
Cleared Nov 12, 1980
GAMMA PI BLOOD GROUP SUBSTANCE
K802534
Gamma Biologicals, Inc.
Hematology · 28d
Cleared May 08, 1980
P1 BLOOD GROUP SUBSTANCE
K800916
Travenol Laboratories, S.A.
Hematology · 16d
Cleared Nov 08, 1977
LEWIS BLOOD GROUP SUBSTANCE
K771487
Ortho Diagnostics, Inc.
Hematology · 95d
Cleared Nov 08, 1977
P1 BLOOD GROUP SUBSTANCE
K771488
Ortho Diagnostics, Inc.
Hematology · 95d

About Product Code KSX - Regulatory Context