K852240 is an FDA 510(k) clearance for the SMS, SCREEN MACHINE SYSTEM. This device is classified as a Fluorometer (Class I - General Controls, product code JZT).
Submitted by Pandex Laboratories, Inc. (Mundelein, US). The FDA issued a Cleared decision on June 11, 1985, 19 days after receiving the submission on May 23, 1985.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4520.
| 510(k) Number | K852240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 1985 |
| Decision Date | June 11, 1985 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZT — Fluorometer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4520 |