The following data is part of a premarket notification filed by Dpc Cirrus with the FDA for Immulite 2000 Carcinoembryonic Antigen (cea) Kit.
| Device ID | K980855 |
| 510k Number | K980855 |
| Device Name: | IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | DPC CIRRUS B13-B18, 111 CANFIELD AVE. Randolph, NJ 07869 |
| Contact | Robert M Di Tullio |
| Correspondent | Robert M Di Tullio DPC CIRRUS B13-B18, 111 CANFIELD AVE. Randolph, NJ 07869 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-05 |
| Decision Date | 1998-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414961125 | K980855 | 000 |
| 00630414961118 | K980855 | 000 |