The following data is part of a premarket notification filed by Exocell, Inc. with the FDA for Acc.u.dial.
| Device ID | K894423 |
| 510k Number | K894423 |
| Device Name: | ACC.U.DIAL |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | EXOCELL, INC. 3508 MARKET ST., SUITE 420 Philadelphia, PA 19104 |
| Contact | Cohen, M.d. |
| Correspondent | Cohen, M.d. EXOCELL, INC. 3508 MARKET ST., SUITE 420 Philadelphia, PA 19104 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-12-27 |