The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Fluoroskan.
| Device ID | K842049 |
| 510k Number | K842049 |
| Device Name: | FLUOROSKAN |
| Classification | Fluorometer |
| Applicant | FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
| Contact | Gerald A Hahn |
| Correspondent | Gerald A Hahn FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
| Product Code | JZT |
| CFR Regulation Number | 866.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-22 |
| Decision Date | 1984-12-03 |