K840257 is an FDA 510(k) clearance for the RAPID IMMUNO-ASSAY SYS. This device is classified as a Kit, Igg, Platelet Associated (Class II - Special Controls, product code LLG).
Submitted by Applied Polytechnology, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984, 87 days after receiving the submission on January 23, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K840257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1984 |
| Decision Date | April 19, 1984 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LLG — Kit, Igg, Platelet Associated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |