The following data is part of a premarket notification filed by Randox Laboratories Ltd with the FDA for Liquid Co2-2 (lco2-2).
| Device ID | K152085 |
| 510k Number | K152085 |
| Device Name: | Liquid CO2-2 (LCO2-2) |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | RANDOX LABORATORIES LTD 55 DIAMOND ROAD Ardmore, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES LTD 55 DIAMOND ROAD Ardmore, GB Bt29 4qy |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2016-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273213959 | K152085 | 000 |