The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen Online Low-cutoff Calibrators.
Device ID | K932548 |
510k Number | K932548 |
Device Name: | ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS |
Classification | Calibrators, Drug Specific |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Contact | Maria Feijoo |
Correspondent | Maria Feijoo ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
Product Code | DLJ |
CFR Regulation Number | 862.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-26 |
Decision Date | 1993-12-29 |