The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Diagnostics Advia Centaur Rubella Igm Assay.
| Device ID | K010668 |
| 510k Number | K010668 |
| Device Name: | BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| 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 | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-06 |
| Decision Date | 2001-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599847 | K010668 | 000 |
| 00630414599830 | K010668 | 000 |
| 00630414201443 | K010668 | 000 |
| 00630414201436 | K010668 | 000 |