The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Chemistry Glucose Hexokinase_3 (gluh_3) Reagent, Models Ref 05001429.
| Device ID | K101854 |
| 510k Number | K101854 |
| Device Name: | ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 |
| Classification | Hexokinase, Glucose |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2011-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596488 | K101854 | 000 |
| 00630414561899 | K101854 | 000 |
| 00630414526812 | K101854 | 000 |