The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Direct Bilirubin.
| Device ID | K152343 |
| 510k Number | K152343 |
| Device Name: | Direct Bilirubin |
| Classification | Enzymatic Method, Bilirubin |
| Applicant | RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD, CRUMLIN County Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD, CRUMLIN County Antrim, GB Bt29 4qy |
| Product Code | JFM |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-19 |
| Decision Date | 2016-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208320 | K152343 | 000 |
| 05055273208313 | K152343 | 000 |