The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Siro Flex Reagent Cartridge And Dimension Sirolimus Calbirator, Models Dr 306, Dc 306.
| Device ID | K081857 |
| 510k Number | K081857 |
| Device Name: | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 |
| Classification | Sirolimus Test System |
| Applicant | Siemens Healthcare Diagnostics Inc. PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | George M Plummer |
| Correspondent | George M Plummer Siemens Healthcare Diagnostics Inc. PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | NRP |
| CFR Regulation Number | 862.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-01 |
| Decision Date | 2008-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768022128 | K081857 | 000 |
| 00842768022111 | K081857 | 000 |