The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Fluorostat Fluorometer.
| Device ID | K822701 |
| 510k Number | K822701 |
| Device Name: | FLUOROSTAT FLUOROMETER |
| Classification | Fluorometer, For Clinical Use |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-07 |
| Decision Date | 1982-10-08 |