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510(k) K781435

Device
Ortho Low Ionic Solution
Applicant
ORTHO DIAGNOSTICS, INC.
510(k) number
K781435
Product code
KSG
Decision
Substantially Equivalent (SESE)
Decision date
1978-09-14
Date received
1978-08-16
Regulation
864.9600
Classification name
Media, Potentiating For In Vitro Diagnostic Use
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 KSG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K812565ELUTION SOLUTIONBiological Corp. of America1981-10-23
K812222EM-XBiological Corp. of America1981-09-23
K800943PENTEX BOVINE ALBUMIN 30% SOLUTIONMiles Laboratories, Inc.1980-05-08
K800189BOVINE ALBUMIN 22% & 30% SOLUTIONSGotham Biologics, Inc.1980-02-13
K791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONOrtho Diagnostics, Inc.1979-10-11
K791113LOW IONIC STRENGTH SOLUTION (LISS)Hyland Therapeutic Div., Travenol Laboratories1979-06-28
K790973LO-IONGamma Biologicals, Inc.1979-06-15
K790776DADE LOW IONIC STRENGTH SOLUITION (LISS)Dade, Baxter Travenol Diagnostics, Inc.1979-05-23
K790498LISS REAGENTFisher Scientific Co., LLC1979-04-03
K781397EM-VBiological Corp. of America1978-09-14
K780413LOW IIONIC STRENGTH SOLUTIONPfizer, Inc.1978-04-24
K780556SPECT RIM (LISS)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-04-24