The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Reference.
| Device ID | K873118 |
| 510k Number | K873118 |
| Device Name: | BIOTROL REFERENCE |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-10 |
| Decision Date | 1987-09-02 |