The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Cyclosporine Extended Range Assay (csae) Flex Reagent Cartridge, Catalog # Df108.
| Device ID | K052017 |
| 510k Number | K052017 |
| Device Name: | CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 |
| Classification | Cyclosporine |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Product Code | MKW |
| CFR Regulation Number | 862.1235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-26 |
| Decision Date | 2005-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005268 | K052017 | 000 |