The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Ige.
| Device ID | K010855 |
| 510k Number | K010855 |
| Device Name: | RANDOX IGE |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-22 |
| Decision Date | 2001-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273203929 | K010855 | 000 |
| 05055273203912 | K010855 | 000 |