The following data is part of a premarket notification filed by Vital Diagnostics (manufacturing) Ptyltd with the FDA for Cpk Reagent.
| Device ID | K112416 |
| 510k Number | K112416 |
| Device Name: | CPK REAGENT |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD 189-199 BROWNS ROAD Noble Park, Victoria, AU 3174 |
| Contact | Melita Lambiris |
| Correspondent | Melita Lambiris VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD 189-199 BROWNS ROAD Noble Park, Victoria, AU 3174 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2011-11-09 |