JKT — Gas Chromatograph, Carbon-Monoxide Class I

FDA Device Classification

FDA product code JKT covers "Gas Chromatograph, Carbon-Monoxide", a Class I medical device regulated under 21 CFR 862.3220. Submissions are reviewed by the Clinical Toxicology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JKT
Device Class
Class I
Regulation Number
862.3220
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K830843rna medicalBLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-April 28, 1983
K823535shaban mfgDILUENT, ZEROING SOLUTION & CO-OX/ISEJanuary 28, 1983