K780441 is an FDA 510(k) clearance for the THEOPHYLLINE ASSAY TO THE CENTRIFICHEM. This device is classified as a U.v. Spectrometry, Theophylline (Class II - Special Controls, product code LCY).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1978, 23 days after receiving the submission on March 20, 1978.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K780441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1978 |
| Decision Date | April 12, 1978 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LCY — U.v. Spectrometry, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |