The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Slide Culture U 'eiken'.
| Device ID | K861631 |
| 510k Number | K861631 |
| Device Name: | SLIDE CULTURE U 'EIKEN' |
| Classification | Kit, Screening, Urine |
| Applicant | SYN-KIT, INC. 9231 ETON AVE. Chatsworth, CA 91311 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey SYN-KIT, INC. 9231 ETON AVE. Chatsworth, CA 91311 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-29 |
| Decision Date | 1986-06-10 |