DDX · Class I · 21 CFR 866.5715

FDA Product Code DDX: Plasminogen, Antigen, Antiserum, Control

Leading manufacturers include Helena Laboratories, E.I. Dupont DE Nemours & Co., Inc. and Instrumentation Laboratory CO.

10
Total
10
Cleared
75d
Avg days
1978
Since

FDA 510(k) Cleared Plasminogen, Antigen, Antiserum, Control Devices (Product Code DDX)

10 devices
1–10 of 10
Cleared Dec 04, 1986
IL TEST 97573-15, PLASMINOGEN ASSAY
K864212
Instrumentation Laboratory CO
Hematology · 37d
Cleared Sep 29, 1981
ACA PLASMINOGEN TEST PACK
K812625
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Jul 02, 1981
HELENA PLASMINOGEN QUIPLATE PROCEDURE
K811777
Helena Laboratories
Immunology · 9d

About Product Code DDX - Regulatory Context