The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Glucose (god/pap).
| Device ID | K003346 |
| 510k Number | K003346 |
| Device Name: | RANDOX GLUCOSE (GOD/PAP) |
| Classification | Glucose Oxidase, Glucose |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Contact | P. Armstrong |
| Correspondent | P. Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-25 |
| Decision Date | 2001-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273203318 | K003346 | 000 |
| 05055273203271 | K003346 | 000 |
| 05055273203240 | K003346 | 000 |
| 05055273203233 | K003346 | 000 |
| 05055273203226 | K003346 | 000 |
| 05055273203202 | K003346 | 000 |
| 05055273203196 | K003346 | 000 |
| 05055273203165 | K003346 | 000 |