The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Advia Centaur And Acs: 180 Folate Immunoassay.
| Device ID | K010050 |
| 510k Number | K010050 |
| Device Name: | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | BAYER DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn BAYER DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-05 |
| Decision Date | 2001-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414570587 | K010050 | 000 |
| 00630414469454 | K010050 | 000 |
| 00630414454597 | K010050 | 000 |
| 00630414451787 | K010050 | 000 |
| 00630414451077 | K010050 | 000 |
| 00630414451060 | K010050 | 000 |
| 00630414450940 | K010050 | 000 |
| 00630414208671 | K010050 | 000 |
| 00630414204192 | K010050 | 000 |