The following data is part of a premarket notification filed by Escreen, Inc. with the FDA for Escreen System.
| Device ID | K003352 |
| 510k Number | K003352 |
| Device Name: | ESCREEN SYSTEM |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | ESCREEN, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ESCREEN, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Product Code | LAF |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-26 |
| Decision Date | 2001-03-20 |