The following data is part of a premarket notification filed by Bayer Healthcare, Diagnostics Division with the FDA for Co2 Calibrator/diluent.
| Device ID | K033643 |
| 510k Number | K033643 |
| Device Name: | CO2 CALIBRATOR/DILUENT |
| Classification | Calibrator, Secondary |
| Applicant | BAYER HEALTHCARE, DIAGNOSTICS DIVISION 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Kenneth T Edds, Ph.d. |
| Correspondent | Kenneth T Edds, Ph.d. BAYER HEALTHCARE, DIAGNOSTICS DIVISION 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-20 |
| Decision Date | 2004-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597447 | K033643 | 000 |
| 00630414227887 | K033643 | 000 |