The following data is part of a premarket notification filed by Breit Laboratories, Inc. with the FDA for Colotrak Occult Blood Test.
| Device ID | K840527 |
| 510k Number | K840527 |
| Device Name: | COLOTRAK OCCULT BLOOD TEST |
| Classification | Reagent, Occult Blood |
| Applicant | BREIT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-07 |
| Decision Date | 1984-09-05 |