KSK · Class II · 21 CFR 864.9400

FDA Product Code KSK: Solution, Stabilized Enzyme

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic and Hyland Therapeutic Div., Travenol Laboratories.

5
Total
5
Cleared
70d
Avg days
1976
Since

FDA 510(k) Cleared Solution, Stabilized Enzyme Devices (Product Code KSK)

5 devices
1–5 of 5
Cleared Jul 27, 1978
AUTOMATED ENZYME
K780962
Hyland Therapeutic Div., Travenol Laboratories
Hematology · 45d
Cleared Jul 20, 1976
AUTOZYME
K760123
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 22d

About Product Code KSK - Regulatory Context