K821862 is an FDA 510(k) clearance for the QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.. This device is classified as a Radioimmunoassay, Theophylline (Class II - Special Controls, product code LCA).
Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982, 12 days after receiving the submission on June 24, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K821862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1982 |
| Decision Date | July 06, 1982 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LCA — Radioimmunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |