K961462 is an FDA 510(k) clearance for the CEDIA THEOPHYLLINE ASSAY. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on June 27, 1996, 71 days after receiving the submission on April 17, 1996.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K961462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1996 |
| Decision Date | June 27, 1996 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |