The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Rxl Max With Streamlab Analytical Workcell And Sample Transfer Module.
| Device ID | K043546 |
| 510k Number | K043546 |
| Device Name: | DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | DADE BEHRING, INC. 500 GBC DR., M/S 514 P.O. BOX 6101 Newark, DE 19714 |
| Contact | Stanley Gorak |
| Correspondent | Stanley Gorak DADE BEHRING, INC. 500 GBC DR., M/S 514 P.O. BOX 6101 Newark, DE 19714 |
| Product Code | CDT |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEC |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CFQ |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGS |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CHI |
| Subsequent Product Code | CIC |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CJW |
| Subsequent Product Code | CKA |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-23 |
| Decision Date | 2005-01-18 |
| Summary: | summary |