The following data is part of a premarket notification filed by Beta Med Pharmaceuticals, Inc. with the FDA for Occult-alert.
| Device ID | K830919 |
| 510k Number | K830919 |
| Device Name: | OCCULT-ALERT |
| Classification | Reagent, Occult Blood |
| Applicant | BETA MED PHARMACEUTICALS, 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 | 1983-03-22 |
| Decision Date | 1983-07-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OCCULT-ALERT 73435285 1288546 Dead/Cancelled |
United States Packaging Corporation 1983-07-19 |