The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Creatinine (cre2) Flex Reagent Cartridge.
| Device ID | K132638 |
| 510k Number | K132638 |
| Device Name: | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE M/S 514 P.O. BOX 6101 Newark, DE 19714 |
| Contact | Laura J Duggan, Ph.d. |
| Correspondent | Laura J Duggan, Ph.d. Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE M/S 514 P.O. BOX 6101 Newark, DE 19714 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-23 |
| Decision Date | 2014-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595009 | K132638 | 000 |