The following data is part of a premarket notification filed by Bio Clinic Co. with the FDA for Tmb Chromogen/substrate Reagent Set.
| Device ID | K920918 |
| 510k Number | K920918 |
| Device Name: | TMB CHROMOGEN/SUBSTRATE REAGENT SET |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BIO CLINIC CO. 5977 SOUTHWEST AVE. St. Louis, MI 63139 |
| Contact | Bruce F Watkins |
| Correspondent | Bruce F Watkins BIO CLINIC CO. 5977 SOUTHWEST AVE. St. Louis, MI 63139 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-28 |
| Decision Date | 1992-04-07 |