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510(k) K964452

Device
HEMATACHEK
Applicant
RICHMOND DIAGNOSTICS, INC.
510(k) number
K964452
Product code
GLK  
Decision
Substantially Equivalent (SESE)
Decision date
1997-02-20
Date received
1996-11-06
Regulation
864.8625
Classification name
Control, Hematocrit
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH P PINENO
Address
100 Jersey Ave., Suite 202a, Bldg. B New Brunswick NJ US 08901 08901

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GLK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121467EUROTROL HEMATOCRIT CONTROLEurotrol B.V.2013-05-10
K021924MEDICA EASYQC HEMATOCRIT CONTROLBionostics, Inc.2002-06-24
K020618AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROLAalto Scientific, Ltd.2002-05-14
K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4Ciba Corning Diagnostics Corp.1996-07-26
K924926MSI-HCTMedical Specialties, Inc.1993-01-07
K893562A.QC HCT LEVEL 1 AND 2Johnson & Johnson Professionals, Inc.1989-07-14

Legacy Summary#

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FDA Review#

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