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510(k) K862047

Device
Coagulator (8 Channel)
Applicant
MED USA
510(k) number
K862047
Product code
KQG
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-29
Date received
1986-05-29
Regulation
864.5400
Classification name
Instrument, Coagulation
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ISMAIL NABIH
Address
23 Bradford St. W. Concord MA US 01742 01742

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050821COAGCARE ANTICOAGULATION MANAGEMENT SYSTEMZycare2005-08-16
K021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONVital Scientific N.V.2002-10-25
K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CPacific Hemostasis1999-09-03
K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200Pacific Hemostasis1999-06-21
K983475HEMOCHRON RESPONSEInternational Technidyne Corp.1999-05-03
K902614ELVI 828 DIGICLOT MULTISCANLogos Scientific, Inc.1990-11-08
K900685CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERTexas Intl. Laboratories, Inc.1990-04-16
K852492COAGULATORMed USA1985-08-13
K851169ELECTRA 800 AUTOMATIC COAGULATION TIMERMedical Laboratory Automation Systems, Inc.1985-06-24
K823131KOAGULAB 40-A AUTOMATED COAGULATION SYSOrtho Diagnostic Systems, Inc.1982-12-09
K812906ELVI BICLOT 816Volu Sol Medical Industries1982-07-22
K791587ELVI 810 CLOTSCANNERVolu Sol Medical Industries1979-09-17
K770914INCUBATOR, PORTABLE, ACT-STATThermolyne Corp.1977-08-04