The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Uibc Reagent.
| Device ID | K912795 |
| 510k Number | K912795 |
| Device Name: | BIOTROL UIBC REAGENT |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Contact | Allan C.murphy |
| Correspondent | Allan C.murphy BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Product Code | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1991-08-12 |