Submission Details
| 510(k) Number | K071603 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2007 |
| Decision Date | June 25, 2008 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
Jun 2008
Decision
379d
Days
Class 2
Risk
About This 510(k) Submission
K071603 is an FDA 510(k) clearance for the DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA), a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on June 25, 2008, 379 days after receiving the submission on June 12, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.
Device Classification
| Product Code | DHX — System, Test, Carcinoembryonic Antigen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
Manufacturer
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