The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Acs:centaur Cea.
| Device ID | K981478 |
| 510k Number | K981478 |
| Device Name: | ACS:CENTAUR CEA |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-24 |
| Decision Date | 1998-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598536 | K981478 | 000 |
| 00630414126302 | K981478 | 000 |
| 00630414175317 | K981478 | 000 |
| 00630414177304 | K981478 | 000 |
| 00630414177311 | K981478 | 000 |
| 00630414204741 | K981478 | 000 |
| 00630414598505 | K981478 | 000 |
| 00630414598512 | K981478 | 000 |
| 00630414598529 | K981478 | 000 |
| 00630414294131 | K981478 | 000 |