The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Chemistry Gluh_3 Reagents.
| Device ID | K120681 |
| 510k Number | K120681 |
| Device Name: | ADVIA CHEMISTRY GLUH_3 REAGENTS |
| Classification | Hexokinase, Glucose |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown, NY 10509 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-06 |
| Decision Date | 2012-05-15 |
| Summary: | summary |