The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Acs: 180 And Advia Centaur Anti-thyroglobulin Immunoassays.
| Device ID | K012777 |
| 510k Number | K012777 |
| Device Name: | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds BAYER CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-20 |
| Decision Date | 2001-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598208 | K012777 | 000 |
| 00630414579214 | K012777 | 000 |
| 00630414579221 | K012777 | 000 |
| 00630414580722 | K012777 | 000 |
| 00630414587899 | K012777 | 000 |
| 00630414587905 | K012777 | 000 |
| 00630414597881 | K012777 | 000 |
| 00630414597898 | K012777 | 000 |
| 00630414597904 | K012777 | 000 |
| 00630414597911 | K012777 | 000 |
| 00630414597928 | K012777 | 000 |
| 00630414460833 | K012777 | 000 |