The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Creatine Kinase Liquid Reagent, Model C519-440.
| Device ID | K072548 |
| 510k Number | K072548 |
| Device Name: | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Kelly Chen |
| Correspondent | Kelly Chen TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-10 |
| Decision Date | 2008-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001617 | K072548 | 000 |
| 10673486001594 | K072548 | 000 |