The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Photon Elite/automated Random Access Im/ch System.
| Device ID | K862674 |
| 510k Number | K862674 |
| Device Name: | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM |
| Classification | Fluorometer |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | Bruni, Phd |
| Correspondent | Bruni, Phd HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Product Code | JZT |
| CFR Regulation Number | 866.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-14 |
| Decision Date | 1986-08-15 |