The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Aldolase Controls Level 2, And Aldolase Control Level 3.
| Device ID | K131776 |
| 510k Number | K131776 |
| Device Name: | ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273200102 | K131776 | 000 |