The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Uniskan Ii.
| Device ID | K861897 |
| 510k Number | K861897 |
| Device Name: | UNISKAN II |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
| Contact | Frank Gregorio |
| Correspondent | Frank Gregorio FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-16 |
| Decision Date | 1986-07-01 |