The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Tox Ammonia Calibrator.
| Device ID | K031683 |
| 510k Number | K031683 |
| Device Name: | TOX AMMONIA CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-30 |
| Decision Date | 2003-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597614 | K031683 | 000 |
| 00630414479286 | K031683 | 000 |