The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Modification To Abuscreen Online For Phencyclidine.
Device ID | K983704 |
510k Number | K983704 |
Device Name: | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE |
Classification | Control, Hemoglobin, Abnormal |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
Contact | Rita Smith |
Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
Product Code | JCM |
CFR Regulation Number | 864.7415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-21 |
Decision Date | 1999-02-10 |
Summary: | summary |