The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Chemistry Creatine Kinase (ck_l) Assay, Advia Chemistry Enzyme 3 Calibrator.
| Device ID | K160724 |
| 510k Number | K160724 |
| Device Name: | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE Newark, DE 19714 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE Newark, DE 19714 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-16 |
| Decision Date | 2016-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597249 | K160724 | 000 |
| 00630414006642 | K160724 | 000 |