ClearanceBrief
Panels › Immunology › Product code KTN · Class 2

System, Test, Infectious Mononucleosis

Regulation 866.5640

0510(k)s in 12 months (59 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
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Top companies in KTN

Company510(k)sRecalls
Alere San Diego, Inc.08
Ampcor, Inc.30
Armkel, LLC30
J.S. Medical Assoc.30
Texas Immunology, Inc.30
Gamma Biologicals, Inc.20
Immunostics Co., Inc.20
Instrumentation Laboratory CO20
Organon, Inc.20
Pacific Biotech, Inc.20
Decided510(k)Device and applicantCode
Jun 13, 1984K841863MONO-TEC
Medilab Corp.
KTN
Apr 5, 1984K840822LEAP MONO TEST KIT
Cooper Biomedical, Inc.
KTN
Feb 10, 1984K834345IM-CHECK
Diagnostic Technology, Inc.
KTN
Mar 17, 1983K830531MONO SCREENING TEST
Tago, Inc.
KTN
Jul 2, 1982K821386SERO/TEX MONO TEST
Texas Immunology, Inc.
KTN
Sep 24, 1981K812540CORDIA IM
Cordis Corp.
KTN
Dec 31, 1979K791455AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
Volu Sol Medical Industries
KTN
Aug 22, 1977K771397MONOSTICON TEST
Organon, Inc.
KTN
Aug 3, 1976K760040TEST, MONO., CARD (MACRO-VUE)
Bd Becton Dickinson Vacutainer Systems Preanalytic
KTN

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