The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Fp Reagen For Amikacin & Amikacin Calibrator.
Device ID | K852317 |
510k Number | K852317 |
Device Name: | COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR |
Classification | Radioimmunoassay, Amikacin |
Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
Contact | Donald Kafader |
Correspondent | Donald Kafader ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
Product Code | KLQ |
CFR Regulation Number | 862.3035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-31 |
Decision Date | 1985-06-25 |