CHG — Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride Class II

FDA Device Classification

FDA product code CHG covers "Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride", a Class II medical device regulated under 21 CFR 862.1170. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
CHG
Device Class
Class II
Regulation Number
862.1170
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K941807intersect systemsINTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENTSeptember 14, 1994
K934588diagnostic chemicalsCHLORIDE (MF) ASSAYFebruary 18, 1994
K903103synermedSYNERMED CHLORIDE REAGENT KITAugust 9, 1990