The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Theophylline.
| Device ID | K011771 |
| 510k Number | K011771 |
| Device Name: | RANDOX THEOPHYLLINE |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | P Armstrong |
| Correspondent | P Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-06 |
| Decision Date | 2002-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273206432 | K011771 | 000 |