The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Diagnostics Advia Centaur Toxoplasma Igm Assay.
| Device ID | K010755 |
| 510k Number | K010755 |
| Device Name: | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | William J Pignato |
| Correspondent | William J Pignato BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-13 |
| Decision Date | 2001-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600154 | K010755 | 000 |
| 00630414600147 | K010755 | 000 |
| 00630414208763 | K010755 | 000 |
| 00630414208442 | K010755 | 000 |