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510(k) K860122

Device
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
Applicant
MEDICAL DEVICE CONSULTANTS, INC.
510(k) number
K860122
Product code
JBP  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-04
Date received
1986-01-14
Regulation
864.7140
Classification name
Activated Whole Blood Clotting Time
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM MORTON
Address
45 W. St. Suite 2 North Attleboro MA US 02703 02703

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JBP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.2023-01-04
K062604RAPIDTEG TEG-ACT TESTHaemoscope Corp.2007-01-31
K032952AIACT KITSienco, Inc.2003-12-12
K023582I-STAT KAOLIN ACT TESTI-Stat Corporation2003-09-08
K020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena Laboratories2002-05-23
K013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena Laboratories2002-01-10
K002528SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONSienco, Inc.2000-08-31
K994194(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINTCardiovascular Diagnostics, Inc.2000-03-28
K992571I-STAT SYSTEMI-Stat Corp.2000-02-10
K992851ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEMRoche Diagnostics Corp.2000-01-14
K984141GBACT + KITSienco, Inc.1999-05-28
K983649MAX-ACTArray Medical, Inc.1998-12-11
K971935B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)B & D Corp.1997-10-01
K964609ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBEArray Medical, Inc.1997-03-06
K960749HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACTInternational Technidyne Corp.1996-08-12

Legacy Summary#

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FDA Review#

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