The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Myoglobin.
| Device ID | K010700 |
| 510k Number | K010700 |
| Device Name: | RANDOX MYOGLOBIN |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Contact | P. Armstromg |
| Correspondent | P. Armstromg RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-08 |
| Decision Date | 2001-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273204681 | K010700 | 000 |
| 05055273204674 | K010700 | 000 |