The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Bayer Diagnostics Acs:180 And Advia Centaur Anti-tpo Assay.
| Device ID | K003291 |
| 510k Number | K003291 |
| Device Name: | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | BAYER DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | William J Pignato |
| Correspondent | William J Pignato BAYER DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-20 |
| Decision Date | 2000-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414973920 | K003291 | 000 |
| 00630414587837 | K003291 | 000 |
| 00630414587844 | K003291 | 000 |
| 00630414587912 | K003291 | 000 |
| 00630414587936 | K003291 | 000 |
| 00630414588476 | K003291 | 000 |
| 00630414597935 | K003291 | 000 |
| 00630414597942 | K003291 | 000 |
| 00630414597959 | K003291 | 000 |
| 00630414597966 | K003291 | 000 |
| 00630414597973 | K003291 | 000 |
| 00630414598437 | K003291 | 000 |
| 00630414457352 | K003291 | 000 |