The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen Online Lsd Reagent (90 Ml Test Kit).
| Device ID | K961436 |
| 510k Number | K961436 |
| Device Name: | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) |
| Classification | Radioimmunoassay, Lsd (125-i) |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Maria Feijoo |
| Correspondent | Maria Feijoo ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | DLB |
| CFR Regulation Number | 862.3580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-15 |
| Decision Date | 1996-06-21 |