GGX — Pipette, Sahli Class I

FDA Device Classification

FDA product code GGX covers "Pipette, Sahli", a Class I medical device regulated under 21 CFR 864.6160. 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
GGX
Device Class
Class I
Regulation Number
864.6160
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K902263trimedyneOPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATIONJuly 23, 1990
K894389catachemCREATININE FOR MANUAL OR AUTOMATED APPLICATIONSOctober 12, 1989