The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Colon Alert Test.
| Device ID | K992759 |
| 510k Number | K992759 |
| Device Name: | COLON ALERT TEST |
| Classification | Reagent, Occult Blood |
| Applicant | IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Vincent P Lastella |
| Correspondent | Vincent P Lastella IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-17 |
| Decision Date | 1999-12-06 |