FDA.reportPublic FDA data

510(k) K780556

Device
Spect Rim (liss)
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K780556
Product code
KSG
Decision
Substantially Equivalent (SESE)
Decision date
1978-04-24
Date received
1978-04-05
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
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

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
K781435ORTHO LOW IONIC SOLUTIONOrtho Diagnostics, Inc.1978-09-14
K780413LOW IIONIC STRENGTH SOLUTIONPfizer, Inc.1978-04-24