The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Glucose (hexokinase) Kit.
| Device ID | K953210 |
| 510k Number | K953210 |
| Device Name: | GLUCOSE (HEXOKINASE) KIT |
| Classification | Hexokinase, Glucose |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-10 |
| Decision Date | 1996-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208764 | K953210 | 000 |
| 05055273203325 | K953210 | 000 |
| 05055273203264 | K953210 | 000 |
| 05055273203257 | K953210 | 000 |
| 05055273203219 | K953210 | 000 |
| 05055273203189 | K953210 | 000 |