The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Exl With Lm Clinical Chemistry System, Dimension Ft4l Flex Reagent Cartridge, And Loci Thyroid Calibrator, Mod.
| Device ID | K073604 |
| 510k Number | K073604 |
| Device Name: | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
| Product Code | CEC |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-21 |
| Decision Date | 2008-03-13 |
| Summary: | summary |