The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Hdlc Flex Reagent Cartridge.
| Device ID | K081300 |
| 510k Number | K081300 |
| Device Name: | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE |
| Classification | Colorimetric Method, Lipoproteins |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Pamela A Jurga |
| Correspondent | Pamela A Jurga SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JHM |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-08 |
| Decision Date | 2008-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768020438 | K081300 | 000 |