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510(k) K911997

Device
TENDERFOOT(R), MODIFICATION
Applicant
INTERNATIONAL TECHNIDYNE CORP.
510(k) number
K911997
Product code
JCA  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-17
Date received
1991-04-22
Regulation
864.6100
Classification name
Device, Bleeding Time
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LES HEIMANN
Address
23 Nevsky St. Edison NJ US 08820 08820

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JCA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K911745SIMPLATE PEDIATRICOrganon Teknika Corp.1991-08-09
K911996SURGICUTT-BLEEDING TIME DEVICE, MODIFICATIONInternational Technidyne Corp.1991-07-17
K871318Q.I.C. BLEEDING TIME DEVICEHelena Laboratories1987-06-10
K850542SURGICUTT - BLEEDING TIME DEVICEInternational Technidyne Corp.1985-03-01
K830645BLEEDING TIME DEVICE DISPOSABLEAmerican Dade1983-03-17
K801815AUTOLETUlster Scientific, Inc.1980-10-10
K761250SIMPLATEGeneral Diagnostics1977-03-01

Legacy Summary#

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FDA Review#

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