The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Re-cell Slide Recap.
Device ID | K772139 |
510k Number | K772139 |
Device Name: | RE-CELL SLIDE RECAP |
Classification | Device, Automated Cell-locating |
Applicant | GEOMETRIC DATA, DIV. SMITHKLINE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JOY |
CFR Regulation Number | 864.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-14 |
Decision Date | 1978-01-05 |