The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Direct Ldl/hdl Cholesterol Calibrator.
| Device ID | K122126 |
| 510k Number | K122126 |
| Device Name: | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR |
| Classification | Calibrator, Primary |
| Applicant | RANDOX LABORATORIES LIMITED 34 DIAMOND ROAD Crumlin Antrim, GA Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES LIMITED 34 DIAMOND ROAD Crumlin Antrim, GA Bt29 4qy |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-18 |
| Decision Date | 2012-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597454 | K122126 | 000 |
| 05055273201239 | K122126 | 000 |