The following data is part of a premarket notification filed by Cyberfluor, Inc. with the FDA for Cyberfluor 615 Immunoanalyzer.
| Device ID | K872803 |
| 510k Number | K872803 |
| Device Name: | CYBERFLUOR 615 IMMUNOANALYZER |
| Classification | Fluorometer, For Clinical Use |
| Applicant | CYBERFLUOR, INC. 179 JOHN ST., 4TH FL., TORONTO Ontario M5t 1x4, CA |
| Contact | James Clelland |
| Correspondent | James Clelland CYBERFLUOR, INC. 179 JOHN ST., 4TH FL., TORONTO Ontario M5t 1x4, CA |
| Product Code | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-15 |
| Decision Date | 1987-09-02 |