The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Innotron Fluorimeter Series One-10.
| Device ID | K822942 |
| 510k Number | K822942 |
| Device Name: | INNOTRON FLUORIMETER SERIES ONE-10 |
| Classification | Fluorometer, For Clinical Use |
| Applicant | INNOTRON OF OREGON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-04 |
| Decision Date | 1982-12-09 |