The following data is part of a premarket notification filed by Pandex Laboratories, Inc. with the FDA for Sms, Screen Machine System.
| Device ID | K852240 |
| 510k Number | K852240 |
| Device Name: | SMS, SCREEN MACHINE SYSTEM |
| Classification | Fluorometer |
| Applicant | PANDEX LABORATORIES, INC. 909 ORCHARD ST. Mundelein, IL 60060 |
| Contact | Mark S Ellis |
| Correspondent | Mark S Ellis PANDEX LABORATORIES, INC. 909 ORCHARD ST. Mundelein, IL 60060 |
| Product Code | JZT |
| CFR Regulation Number | 866.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-23 |
| Decision Date | 1985-06-11 |