JBQ · Class II · 21 CFR 864.7060

FDA Product Code JBQ: Antithrombin Iii Quantitation

Leading manufacturers include Instrumentation Laboratory CO, Sigma Diagnostics, Inc. and Pharmaseal Div., Baxter Healthcare Corp..

56
Total
56
Cleared
102d
Avg days
1977
Since
56 devices
25–48 of 56
Cleared Jan 24, 1991
LIATEST(R) AT III TEST KIT
K905110
American Bioproducts Co.
Hematology · 72d
Cleared Sep 25, 1990
COACUTE ANTITHROMBIN CHROMOGENIC ASSAY
K902393
Kabi Diagnostica
Hematology · 118d
Cleared Aug 09, 1990
SPECTROLYSE ATIII KIT
K902530
Biopool AB
Hematology · 65d
Cleared Aug 06, 1990
BECKMAN ANTITHROMBIN III REAGENT KIT
K901977
Beckman Instruments, Inc.
Hematology · 96d
Cleared Mar 15, 1990
ORTHOKROME* ANTITHROMBIN
K900400
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Jun 23, 1989
ACTICHROME ATIII KIT
K893608
American Diagnostic Corp.
Hematology · 44d
Cleared Dec 20, 1988
TURBOX ANTITHROMBIN III
K884144
Unipath , Ltd.
Hematology · 81d
Cleared Nov 23, 1988
BERICHROM(R) ANTITHROMBIN III
K883662
Behring Diagnostics, Inc.
Hematology · 89d
Cleared Apr 27, 1988
ENZYGNOST(R) TAT REAGENTS
K880700
Behring Diagnostics, Inc.
Hematology · 65d
Cleared Mar 16, 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315
Baxter Healthcare Corp
Hematology · 50d
Cleared Nov 25, 1986
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214
Instrumentation Laboratory CO
Hematology · 28d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412
Warner-Lambert Co.
Hematology · 93d
Cleared Sep 06, 1984
IL TEST ANTITHROMBIN III ACTIVITY
K841736
Instrumentation Laboratory CO
Hematology · 132d
Cleared Sep 29, 1983
DIACROM * ATIII
K832592
Wellcome Diagnostics
Immunology · 58d
Cleared Aug 12, 1983
RABBIT ANTI-HUMAN ANTITHROMBIN III
K832268
Gelco Diagnostics, Inc.
Hematology · 43d
Cleared Aug 11, 1983
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
K831961
Kent Laboratories, Inc.
Chemistry · 55d
Cleared Jun 08, 1983
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297
American Dade
Chemistry · 48d
Cleared Dec 30, 1981
COATEST ANTITHROMBIN
K812829
Kabivitrum, Inc.
Hematology · 83d
Cleared Nov 24, 1981
ACA ANTITHROMBIN III PLASMINOGEN CALIB
K812626
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 70d
Cleared Oct 08, 1981
ACA ANTITHROMBIN III TEST PACK
K812627
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 23d
Cleared Sep 01, 1981
ANTITHROMBIN III SCREEN KIT
K812215
Pacific Hemostasis
Hematology · 27d
Cleared Dec 22, 1980
HELENA AT-III QUIPLATE PROCEDURE
K802912
Helena Laboratories
Hematology · 34d
Cleared Nov 05, 1979
PHADECODE XA INHIBITOR ASSAY
K792019
Pharmaseal Div., Baxter Healthcare Corp.
Hematology · 27d
Cleared Feb 26, 1979
DETERMINATION OF ANTITHROMBIN III, 885
K790090
Sigma Chemical Co.
Hematology · 41d