GKP · Class II · 21 CFR 864.5400

FDA Product Code GKP: Instrument, Coagulation, Automated

Leading manufacturers include Dade Behring, Inc., Instrumentation Laboratory CO and Helena Laboratories.

49
Total
49
Cleared
108d
Avg days
1982
Since
49 devices
25–48 of 49
Cleared Feb 01, 1995
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117
American Bioproducts Co.
Hematology · 274d
Cleared Dec 22, 1994
HEMOLAB
K931992
Biomerieux Vitek, Inc.
Hematology · 608d
Cleared Aug 23, 1993
CASCADE M, CAT. NO. 1710
K931956
Helena Laboratories
Hematology · 125d
Cleared Jun 18, 1993
IL MCL-2 COAGULATION ANALYZER
K924098
Instrumentation Laboratory CO
Hematology · 309d
Cleared Jun 29, 1992
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
K921465
Helena Laboratories
Hematology · 94d
Cleared Jun 09, 1992
CASCADE 480
K921363
Helena Laboratories
Hematology · 81d
Cleared Jan 13, 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
K914946
Helena Laboratories
Hematology · 76d
Cleared Nov 13, 1990
ST-4 COAGULATION INSTRUMENT
K904297
American Bioproducts Co.
Hematology · 55d
Cleared May 25, 1990
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
K901380
Helena Laboratories
Hematology · 64d
Cleared May 22, 1990
KOAGULAB 60-S COAGULATION SYSTEM
K901120
Ortho Diagnostic Systems, Inc.
Hematology · 71d
Cleared Feb 03, 1989
KOAGULAB* 32-S COAGULATION SYSTEM
K885035
Ortho Diagnostic Systems, Inc.
Hematology · 60d
Cleared May 18, 1988
COAG-A-MATE(R) XM
K881281
Organon Teknika Corp.
Hematology · 54d
Cleared Jan 28, 1982
COAG-A-MATE X2
K813564
General Diagnostics
Hematology · 37d