The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Calibration Serum Level 1 & 2.
| Device ID | K955489 |
| 510k Number | K955489 |
| Device Name: | CALIBRATION SERUM LEVEL 1 & 2 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | Julie Taylor |
| Correspondent | Julie Taylor RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-27 |
| Decision Date | 1996-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817439020338 | K955489 | 000 |