The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Gentamicin.
| Device ID | K012978 |
| 510k Number | K012978 |
| Device Name: | RANDOX GENTAMICIN |
| Classification | Enzyme Immunoassay, Gentamicin |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-06 |
| Decision Date | 2001-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273206449 | K012978 | 000 |