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 |