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 |