DDX · Class I · 21 CFR 866.5715

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

Leading manufacturers include Dade, Baxter Travenol Diagnostics, Inc., Helena Laboratories and E.I. Dupont DE Nemours & Co., Inc..

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 Sep 09, 1994
PLASMINOGEN RID TEST KIT
K941346
The Binding Site, Ltd.
Immunology · 172d
Cleared Jan 04, 1989
BERICHROM(R) PLASMINOGEN
K884766
Behring Diagnostics, Inc.
Immunology · 51d
Cleared Dec 04, 1986
IL TEST 97573-15, PLASMINOGEN ASSAY
K864212
Instrumentation Laboratory CO
Hematology · 37d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
K850410
Warner-Lambert Co.
Immunology · 93d
Cleared Nov 21, 1983
DIACROM *PLG
K832591
Wellcome Diagnostics
Immunology · 111d
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
Cleared Nov 15, 1978
PLASMINOGEN ASSAY
K781478
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 79d
Cleared Jan 24, 1978
LAS-R HUMAN PLASMINOGEN TEST
K772085
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 81d

About Product Code DDX - Regulatory Context