COLOSCREEN
Reagent, Occult Blood
HELENA LABORATORIES
The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Coloscreen.
Pre-market Notification Details
| Device ID | K911075 |
| 510k Number | K911075 |
| Device Name: | COLOSCREEN |
| Classification | Reagent, Occult Blood |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-11 |
| Decision Date | 1991-07-03 |
Trademark Results [COLOSCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COLOSCREEN 73472763 1326715 Live/Registered |
Helena Laboratories Corporation 1984-03-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.