The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Triglycerides Gpo-pap.
| Device ID | K923508 |
| 510k Number | K923508 |
| Device Name: | TRIGLYCERIDES GPO-PAP |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Contact | Joh Lamont |
| Correspondent | Joh Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-15 |
| Decision Date | 1993-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414209708 | K923508 | 000 |