The following data is part of a premarket notification filed by Robert C. Leif, Ph.d. with the FDA for Leif Centrifugal Cytology Bucket.
Device ID | K792032 |
510k Number | K792032 |
Device Name: | LEIF CENTRIFUGAL CYTOLOGY BUCKET |
Classification | Cytocentrifuge |
Applicant | ROBERT C. LEIF, PH.D. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IFB |
CFR Regulation Number | 864.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-10 |
Decision Date | 1979-11-30 |