The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Liquid Ck-mb, Randox Ck-mb Calibrator.
| Device ID | K123977 |
| 510k Number | K123977 |
| Device Name: | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| 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 | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273213973 | K123977 | 000 |
| 05055273201451 | K123977 | 000 |