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 |