K842018 is an FDA 510(k) clearance for the ISO-SEP SYSTEM. This device is classified as a Chromatographic Separation, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code CEX).
Submitted by Berwick Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1984, 133 days after receiving the submission on May 18, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K842018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1984 |
| Decision Date | September 28, 1984 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEX — Chromatographic Separation, Lactate Dehydrogenase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1445 |