The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Revised Labeling For Lsd Test Kit.
Device ID | K874270 |
510k Number | K874270 |
Device Name: | REVISED LABELING FOR LSD TEST KIT |
Classification | Radioimmunoassay, Lsd (125-i) |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
Contact | Adrienne Choma |
Correspondent | Adrienne Choma 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 | 1987-10-20 |
Decision Date | 1987-11-13 |