GGH — Iron Stains Class I

FDA Device Classification

FDA product code GGH covers "Iron Stains", a Class I medical device regulated under 21 CFR 864.1850. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification details

Product Code
GGH
Device Class
Class I
Regulation Number
864.1850
Submission Type
510(k) Exempt
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K884011Scientific Device LaboratorySNAP N' STAIN IRON STAINOct 6, 1988

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.