The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Coloscreen-es.
| Device ID | K003359 |
| 510k Number | K003359 |
| Device Name: | COLOSCREEN-ES |
| 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 | 2000-10-27 |
| Decision Date | 2000-11-27 |