510(k) K991321

Device: PACIFIC HEMOSTASIS THROMBOSCREEN 200
Applicant: PACIFIC HEMOSTASIS
510(k) number: K991321
Product code: KQG
Decision: Substantially Equivalent (SESE)
Decision date: 1999-06-21
Date received: 1999-04-19
Regulation: 864.5400
Classification name: Instrument, Coagulation
Medical specialty: Hematology
Review panel: Hematology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: LARRY KOPYTA
Address: 11515 Vanstory Dr. Huntersville NC US 28078 28078

FDA Registration Numbers#

3002721930
1181121
1217183
1220649

Source Documents#

Other 510(k) Records For Product Code KQG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K050821	COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM	Zycare	2005-08-16
K021976	FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON	Vital Scientific N.V.	2002-10-25
K992130	PACIFIC HEMOSTASIS THROMBOSCREEN 400C	Pacific Hemostasis	1999-09-03
K983475	HEMOCHRON RESPONSE	International Technidyne Corp.	1999-05-03
K902614	ELVI 828 DIGICLOT MULTISCAN	Logos Scientific, Inc.	1990-11-08
K900685	CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER	Texas Intl. Laboratories, Inc.	1990-04-16
K862047	COAGULATOR (8 CHANNEL)	Med USA	1986-09-29
K852492	COAGULATOR	Med USA	1985-08-13
K851169	ELECTRA 800 AUTOMATIC COAGULATION TIMER	Medical Laboratory Automation Systems, Inc.	1985-06-24
K823131	KOAGULAB 40-A AUTOMATED COAGULATION SYS	Ortho Diagnostic Systems, Inc.	1982-12-09
K812906	ELVI BICLOT 816	Volu Sol Medical Industries	1982-07-22
K791587	ELVI 810 CLOTSCANNER	Volu Sol Medical Industries	1979-09-17
K770914	INCUBATOR, PORTABLE, ACT-STAT	Thermolyne Corp.	1977-08-04

Legacy Summary#

summary

FDA Review#

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