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510(k) K843608

Device
CAPILLARY BLOOD COLLECTION TUBE
Applicant
MEDICAL TECHNOMICS, LTD.
510(k) number
K843608
Product code
GIO  
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-30
Date received
1984-09-13
Regulation
864.6150
Classification name
Tube, Collection, Capillary Blood
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DENNIS A ALDRED
Address
274 Cottage Hill Ave. Elmhurst IL US 60126 60126

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GIO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972969QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEMInnovative Medical Technologies, Inc.1997-09-22
K941291MONOJECT SAMPLETTE SEPARATOR TUBESherwood Medical Co.1994-10-27
K894851TRU-TRAXHumagen, Inc.1989-09-29
K885324HEMA(PRO)TEC(TION)Medical Products Search, Inc.1989-02-17
K885138CAPILLARY TUBE, BLOOD COLLECTIONCoeur Laboratories, Inc.1989-02-07
K884623SAFE-TEC CAPILLARY BLOOD COLLECTION TUBESafe-Tec Clinical Products, Inc.1988-12-01
K881262CARAWAY TUBES, HEPARIN AND PLAINHelps Products, Inc.1988-05-06
K881187NATELSON TUBES, HEPARIN AND PLAINHelps Products, Inc.1988-05-06
K875061MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATORSherwood Medical Co.1988-01-12
K873647VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBEVentrex Laboratories, Inc.1987-10-20
K850806CORNING BLOOD COLLECTION CAPILLARY TUBESCorning Medical & Scientific1985-03-25
K843892MICRO HEMATOCRIT CAPILLARY TUBESAbco Dealers, Inc.1984-11-13
K843362RINGCAPSMedical Technomics, Ltd.1984-09-21
K843361MINICAPSMedical Technomics, Ltd.1984-09-21
K832578MONOJET SAMPLETTE ADAPTERSSherwood Medical Co.1983-08-31

Legacy Summary#

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FDA Review#

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