The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (cea).
| Device ID | K071603 |
| 510k Number | K071603 |
| Device Name: | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | DADE BEHRING, INC. GLASGOW SITE, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons DADE BEHRING, INC. GLASGOW SITE, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-12 |
| Decision Date | 2008-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768019920 | K071603 | 000 |