The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abiscreen Online For Cannabinoids - Es 50/100.
| Device ID | K961620 |
| 510k Number | K961620 |
| Device Name: | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 |
| Classification | Radioimmunoassay, Cannabinoid(s) |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Contact | Maria Feijoo |
| Correspondent | Maria Feijoo ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -1760 |
| Product Code | LAT |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-26 |
| Decision Date | 1996-06-13 |