Submission Details
| 510(k) Number | K071597 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2007 |
| Decision Date | June 04, 2008 |
| Days to Decision | 358 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
Jun 2008
Decision
358d
Days
Class 2
Risk
About This 510(k) Submission
K071597 is an FDA 510(k) clearance for the DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600, a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II — Special Controls, product code LOJ), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on June 4, 2008, 358 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 | LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
Manufacturer
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