K833841 is an FDA 510(k) clearance for the IL TEST IGG IGA & IGM KITS. This device is classified as a Iga, Rhodamine, Antigen, Antiserum, Control (Class II - Special Controls, product code CZK).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984, 58 days after receiving the submission on November 7, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K833841 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1983 |
| Decision Date | January 04, 1984 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CZK — Iga, Rhodamine, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |