The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Dimension Exl With Lm System.
| Device ID | K130276 |
| 510k Number | K130276 |
| Device Name: | DIMENSION EXL WITH LM SYSTEM |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE M/S 514 P.O. BOX 6101 Newark, DE 19714 -3026 |
| Contact | Pamela A Jurga |
| Correspondent | Pamela A Jurga SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE M/S 514 P.O. BOX 6101 Newark, DE 19714 -3026 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-05 |
| Decision Date | 2013-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414014128 | K130276 | 000 |
| 00842768030024 | K130276 | 000 |
| 00630414014135 | K130276 | 000 |