The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Benzodiazepine Class Assay.
Device ID | K050179 |
510k Number | K050179 |
Device Name: | RANDOX BENZODIAZEPINE CLASS ASSAY |
Classification | Enzyme Immunoassay, Benzodiazepine |
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 | JXM |
CFR Regulation Number | 862.3170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-26 |
Decision Date | 2005-05-17 |