The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Acs:180 And Advia Centaur Ipth Immunoassay.
| Device ID | K020217 |
| 510k Number | K020217 |
| Device Name: | ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-22 |
| Decision Date | 2002-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414979410 | K020217 | 000 |
| 00630414587486 | K020217 | 000 |
| 00630414579207 | K020217 | 000 |
| 00630414579191 | K020217 | 000 |
| 00630414587479 | K020217 | 000 |
| 00630414579184 | K020217 | 000 |
| 00630414579177 | K020217 | 000 |
| 00630414472553 | K020217 | 000 |