The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Randox Aldolase Calibration Serum.
| Device ID | K142181 |
| 510k Number | K142181 |
| Device Name: | RANDOX ALDOLASE CALIBRATION SERUM |
| Classification | Calibrator, Secondary |
| Applicant | RANDOX LABORATORIES LIMITED 55 DIAMOND RD. Crumlin, Co.antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES LIMITED 55 DIAMOND RD. Crumlin, Co.antrim, GB Bt29 4qy |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-08 |
| Decision Date | 2014-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273200089 | K142181 | 000 |