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 |