The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen Radioimmunoassay For Lsd W/ Ref Standard.
| Device ID | K860525 |
| 510k Number | K860525 |
| Device Name: | ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD |
| Classification | Radioimmunoassay, Lsd (125-i) |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Contact | Kafader Ii |
| Correspondent | Kafader Ii ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Product Code | DLB |
| CFR Regulation Number | 862.3580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-11 |
| Decision Date | 1986-04-11 |