The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Assayed Specific Protein Control.
| Device ID | K972608 |
| 510k Number | K972608 |
| Device Name: | RANDOX ASSAYED SPECIFIC PROTEIN CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | P. Armstrong |
| Correspondent | P. Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-11 |
| Decision Date | 1997-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273204919 | K972608 | 000 |
| 05055273204902 | K972608 | 000 |
| 05055273204896 | K972608 | 000 |