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KSG — Media, Potentiating For In Vitro Diagnostic Use Class II

FDA Device Classification

Classification Details

Product Code
KSG
Device Class
Class II
Regulation Number
864.9600
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K812565biological corp. of americaELUTION SOLUTIONOctober 23, 1981
K812222biological corp. of americaEM-XSeptember 23, 1981
K800943miles laboratoriesPENTEX BOVINE ALBUMIN 30% SOLUTIONMay 8, 1980
K800189gotham biologicsBOVINE ALBUMIN 22% & 30% SOLUTIONSFebruary 13, 1980
K791791ortho diagnosticsORTHO ANTIBODY ENHANCEMENT SOLUTIONOctober 11, 1979
K791113hyland therapeutic div., travenol laboratoriesLOW IONIC STRENGTH SOLUTION (LISS)June 28, 1979
K790973gamma biologicalsLO-IONJune 15, 1979
K790776dade, baxter travenol diagnosticsDADE LOW IONIC STRENGTH SOLUITION (LISS)May 23, 1979
K790498fisher scientific coLISS REAGENTApril 3, 1979
K781435ortho diagnosticsORTHO LOW IONIC SOLUTIONSeptember 14, 1978
K781397biological corp. of americaEM-VSeptember 14, 1978
K780556bd becton dickinson vacutainer systems preanalyticSPECT RIM (LISS)April 24, 1978
K780413pfizerLOW IIONIC STRENGTH SOLUTIONApril 24, 1978