The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Bicarbonate Standards.
| Device ID | K921855 |
| 510k Number | K921855 |
| Device Name: | BIOTROL BICARBONATE STANDARDS |
| Classification | Calibrator, Primary |
| Applicant | BIOTROL, USA, INC. 115 SUMMIT DR. Exton, PA 19341 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. 115 SUMMIT DR. Exton, PA 19341 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-17 |
| Decision Date | 1992-08-03 |