The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Acs:180 & Advia Centaur Afp Immunoassay.
| Device ID | K020806 |
| 510k Number | K020806 |
| Device Name: | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Applicant | BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
| Product Code | LOJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-12 |
| Decision Date | 2002-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598376 | K020806 | 000 |
| 00630414598369 | K020806 | 000 |
| 00630414294117 | K020806 | 000 |