KSL — Solution, Copper Sulfate For Specific Gravity Determinations Class I

FDA Device Classification

FDA product code KSL covers "Solution, Copper Sulfate For Specific Gravity Determinations", a Class I medical device regulated under 21 CFR 864.9320. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KSL
Device Class
Class I
Regulation Number
864.9320
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K882101portable medical laboratoriesHEMOGLOBIN SCREENING DEVICEJuly 1, 1988
K803095accra laboratoriesCOPPER SULFATE SOLUTION SP. GR.1.055March 6, 1981