The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia Cantaur And Acs:180 Insulin Calibrator.
| Device ID | K021535 |
| 510k Number | K021535 |
| Device Name: | ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2002-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414461014 | K021535 | 000 |