The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Chemistry Triglycerides_2 (trig_2) Reagent.
| Device ID | K133067 |
| 510k Number | K133067 |
| Device Name: | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown, NY 10591 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown, NY 10591 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2013-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596495 | K133067 | 000 |
| 00630414590394 | K133067 | 000 |
| 00630414526829 | K133067 | 000 |