The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Bayer Diagnostics Advia Centaur Toxoplasma Igg Assay.
| Device ID | K012183 |
| 510k Number | K012183 |
| Device Name: | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | BAYER DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | Barbara Preisel-simmons |
| Correspondent | Barbara Preisel-simmons BAYER DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-12 |
| Decision Date | 2001-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600130 | K012183 | 000 |
| 00630414208756 | K012183 | 000 |