The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Cholesterol Enzymatic Endpoint.
| Device ID | K923504 |
| 510k Number | K923504 |
| Device Name: | CHOLESTEROL ENZYMATIC ENDPOINT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-15 |
| Decision Date | 1994-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273201284 | K923504 | 000 |
| 00630414561073 | K923504 | 000 |
| 00630414526744 | K923504 | 000 |