The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol-33 Plus Pathologique Assayed Chem. Control.
| Device ID | K872777 |
| 510k Number | K872777 |
| Device Name: | BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIOTROL, USA, INC. P.O. BOX 562 Berwyn, PA 19312 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. P.O. BOX 562 Berwyn, PA 19312 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-14 |
| Decision Date | 1987-08-26 |