The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Cyclosporine (csa) Flex Reagent Cartridge.
| Device ID | K023065 |
| 510k Number | K023065 |
| Device Name: | CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE |
| Classification | Cyclosporine |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Lorraine Piestrak |
| Correspondent | Lorraine Piestrak DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 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 | 2002-09-16 |
| Decision Date | 2002-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768025136 | K023065 | 000 |