K905521 is an FDA 510(k) clearance for the CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION. This device is classified as a Fluorescent Immunoassay, Theophylline (Class II - Special Controls, product code LER).
Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on December 26, 1990, 19 days after receiving the submission on December 7, 1990.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K905521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1990 |
| Decision Date | December 26, 1990 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LER — Fluorescent Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |