IBM — Microscope, Phase Contrast Class I

FDA Device Classification

FDA product code IBM covers "Microscope, Phase Contrast", a Class I medical device regulated under 21 CFR 864.3600. Submissions are reviewed by the Pathology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
IBM
Device Class
Class I
Regulation Number
864.3600
Submission Type
Review Panel
PA
Medical Specialty
Pathology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K885091technalysisHEMAVIEW DARKFIELD MICROSCOPE SYSTEMJune 13, 1989