Panels › Hematology › Product code JPA · Class 2

System, Multipurpose For In Vitro Coagulation Studies

Regulation 864.5425

1510(k)s in 12 months (181 all time)

1recalls in 12 months (44 all time)

40recalls that name a 510(k)

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Top companies in JPA

Company	510(k)s	Recalls
Instrumentation Laboratory	12	11
Bio/Data Corp.	13	0
Dade Behring, Inc.	12	1
Diagnostica Stago, Inc.	6	6
International Technidyne Corp.	9	2
Haemonetics	5	5
Helena Laboratories	8	1
Sigma Diagnostics, Inc.	8	0
Siemens Healthcare Diagnostics	2	4
Siemens Healthcare Diagnostics Products GmbH	6	0

Decided	510(k)	Device and applicant	Code
Apr 20, 1993	K930849	VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA Organon Teknika Corp.	JPA
Mar 23, 1993	K925340	COAGULATION CONTROL CONTAINING HEMOGLOBIN Analytical Control Systems, Inc.	JPA
Feb 12, 1993	K926222	OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 Helena Laboratories	JPA
Jan 21, 1993	K923761	ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM International Technidyne Corp.	JPA
Dec 21, 1992	K924509	CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION Behring Diagnostics, Inc.	JPA
Dec 18, 1992	K924453	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180) Organon Teknika Corp.	JPA
Dec 1, 1992	K924124	BEHRING FIBRINTIMER A Behring Diagnostics, Inc.	JPA
Nov 16, 1992	K924393	STANDARD HUMAN PLASMA Behring Diagnostics, Inc.	JPA
Aug 26, 1992	K914188	KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM Ortho Diagnostic Systems, Inc.	JPA
Sep 19, 1991	K912087	ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS Instrumentation Laboratory CO	JPA
Jul 24, 1991	K912061	HEPARIN ADSORBENT Sigma Diagnostics, Inc.	JPA
Aug 1, 1990	K902458	ACS 0.02 M CALCIUM CHLORIDE Analytical Control Systems, Inc.	JPA
Apr 16, 1990	K900917	COAG-A-MATE - RA4 Organon Teknika Corp.	JPA
Mar 12, 1990	K900506	MODIFIED COATRON II AND COATRON JR. Astral Medical Systems	JPA
Mar 6, 1990	K900377	COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN Baxter Healthcare Corp	JPA
Sep 5, 1989	K894466	HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc.	JPA
Sep 5, 1989	K894359	CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc.	JPA
Jun 23, 1989	K893650	PLATELET AGGREGATION PROFILER MODEL PAP-4C Bio/Data Corp.	JPA
Jan 24, 1989	K884534	PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER Pall Biomedical Products Co.	JPA
Dec 30, 1988	K885076	COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE Organon Teknika Corp.	JPA
Nov 1, 1988	K883689	ORTHO OWREN'S BUFFER Ortho Diagnostic Systems, Inc.	JPA
Oct 31, 1988	K883640	KD ONE-STAGE PROTHROMBIN TIME TEST King Diagnostics, Inc.	JPA
Oct 31, 1988	K883637	KD 0.02 M CALCIUM CHLORIDE SOLUTION King Diagnostics, Inc.	JPA
Oct 31, 1988	K883635	KD 0.1 M SODIUM CITRATE SOLUTION King Diagnostics, Inc.	JPA
Aug 25, 1988	K883484	OWREN'S VERONAL BUFFER Helena Laboratories	JPA
Aug 25, 1988	K882444	COAG-I ANALYZER, ALPHA MODEL Cardiovascular Diagnostic Services	JPA
Jun 27, 1988	K881367	ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS Instrumentation Laboratory CO	JPA
Mar 18, 1988	K880713	CLP 0.1 M SODIUM CITRATE SOLUTION Creative Laboratory Products, Inc.	JPA
Mar 9, 1988	K875089	HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN Hemotec, Inc.	JPA
Jul 9, 1987	K872377	CHROM-TROL Helena Laboratories	JPA
Jun 1, 1987	K870831	PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA International Technidyne Corp.	JPA
Apr 23, 1987	K870771	PT HEPARIN ADSORBENT Probe-Tek, Inc.	JPA
Apr 20, 1987	K870687	COAGULATION CONTROL, LEVEL III U. S. Diagnostics, Inc.	JPA
Apr 20, 1987	K870686	COAGULATION CONTROL, LEVEL II U. S. Diagnostics, Inc.	JPA
Apr 20, 1987	K870685	COAGULATION CONTROL, LEVEL I U. S. Diagnostics, Inc.	JPA
Mar 31, 1987	K870688	O.O2 M CALCIUM CHLORIDE SOLUTION U. S. Diagnostics, Inc.	JPA
Mar 17, 1987	K870960	COAG-A-MATE(R) XC Organon Teknika Corp.	JPA
Feb 6, 1987	K864534	ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc.	JPA
Feb 6, 1987	K864532	ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc.	JPA
Nov 25, 1986	K864271	IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA Instrumentation Laboratory CO	JPA
Jul 21, 1986	K862537	*KOAGULAB M COAGULATION SYSTEM** Ortho Diagnostic Systems, Inc.	JPA
May 23, 1986	K860719	BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) Biotrack, Inc.	JPA
Mar 12, 1986	K854938	COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. Diatech, Inc.	JPA
Mar 4, 1986	K860342	MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP Bio/Data Corp.	JPA
Jan 7, 1986	K854546	MICROSAMPLE COAGULATION ANALYSER MODEL 110P Bio/Data Corp.	JPA
Jan 6, 1986	K854090	DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT Diatech, Inc.	JPA
Jan 6, 1986	K854089	DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT Diatech, Inc.	JPA
Dec 4, 1985	K854376	HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc.	JPA
Nov 12, 1985	K853986	THROMBOPLASTIN-R REAGENT American Dade	JPA
Nov 5, 1985	K853328	KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS Ortho Diagnostic Systems, Inc.	JPA

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