The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Bilirubin.
| Device ID | K973995 |
| 510k Number | K973995 |
| Device Name: | RANDOX BILIRUBIN |
| Classification | Hemoglobinometer |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | P Armstrong |
| Correspondent | P Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | GIG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-21 |
| Decision Date | 1997-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273200867 | K973995 | 000 |
| 05055273200850 | K973995 | 000 |
| 05055273200843 | K973995 | 000 |
| 05055273200836 | K973995 | 000 |
| 05055273200829 | K973995 | 000 |
| 05055273200812 | K973995 | 000 |
| 05055273200799 | K973995 | 000 |
| 05055273200782 | K973995 | 000 |