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510(k) K800310

Device
ORTHO ANTISERA CONTROL
Applicant
ORTHO DIAGNOSTICS, INC.
510(k) number
K800310
Product code
KSF  
Decision
Substantially Equivalent (SESE)
Decision date
1980-03-05
Date received
1980-02-12
Regulation
864.9650
Classification name
Kit, Quality Control For Blood Banking Reagents
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K811713AVI-D CONTROLOrtho Diagnostic Systems, Inc.1981-10-23
K810599DADE RH CONTROL REAGENTAmerican Dade1981-03-31
K801425RH CONTROLNorth American Biologicals, Inc.1980-07-14
K800658RST-SERIES CONTROLGamma Biologicals, Inc.1980-04-16
K800239RH-HR NEGATIVE CONTROL REAGENTGotham Biologics, Inc.1980-02-21
K790249TEST CELLSHyland Therapeutic Div., Travenol Laboratories1979-05-16
K790025COUNTER CHECK, H001, H002, H003Diagnostic Technology, Inc.1979-01-17
K780665RECAPBca Biological Corp. of America1978-06-06
K780097QUALITY CONTROL SYSTEM, SPECTRABd Becton Dickinson Vacutainer Systems Preanalytic1978-04-24
K771814REAGENT CONFIDENCE SERAOrtho Diagnostics, Inc.1977-11-07
K761284UNIVAL CONTROL CELLSDade, Baxter Travenol Diagnostics, Inc.1977-01-25

Legacy Summary#

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FDA Review#

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