FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K961892 |
ANALYTICAL CONTROL SYSTEMS, INC. |
SPECKTIN-LA TEST SET |
03/07/1997 |
K955450 |
BEHRING DIAGNOSTICS, INC. |
PATHROMTIN SL |
04/19/1996 |
K014028 |
CARESIDE HEMOTOLOGY, INC. |
CARESIDE APTT |
02/08/2002 |
K053111 |
DIAGNOSTICA STAGO, INC. |
STA-CEPHASCREEN KIT |
05/04/2006 |
K050221 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL SILICA CLOTTING TIME |
03/30/2005 |
K160445 |
INSTRUMENTATION LABORATORY CO. |
HemosIL Silica Clotting Time |
03/16/2016 |
K060688 |
INSTRUMENTATION LABORATORY CO. |
HEMOSIL SYNTHASIL |
04/13/2006 |
K973306 |
INSTRUMENTATION LABORATORY CO. |
IL TEST APTT-SP |
11/04/1997 |
K972831 |
INTERNATIONAL TECHNIDYNE CORP. |
HEMOCHRON CITRATE APTT |
11/20/1997 |
K014008 |
ITC, INC. |
HEMOCHRON JR. CITRATE APTT CUVETTE |
01/24/2002 |
K955638 |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
SYNTHAFAX APTT REAGENT |
04/23/1996 |
K193556 |
Precision BioLogic |
Cryocheck Hex LA |
10/23/2020 |
K992711 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 |
12/06/1999 |
K992712 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 |
12/06/1999 |
K022021 |
VITAL SCIENTIFIC N.V. |
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT |
11/01/2002 |