The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Amikacin.
Device ID | K033884 |
510k Number | K033884 |
Device Name: | RANDOX AMIKACIN |
Classification | Radioimmunoassay, Amikacin |
Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
Contact | Pauline Armstrong |
Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
Product Code | KLQ |
CFR Regulation Number | 862.3035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-15 |
Decision Date | 2004-06-09 |