K070810 is an FDA 510(k) clearance for the ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F). This device is classified as a Fluorescence Polarization Immunoassay, Theophylline (Class II - Special Controls, product code LGS).
Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on June 8, 2007, 74 days after receiving the submission on March 26, 2007.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K070810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2007 |
| Decision Date | June 08, 2007 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LGS — Fluorescence Polarization Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |