The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Rcrp Flex Reagent Cartridge.
| Device ID | K003419 |
| 510k Number | K003419 |
| Device Name: | RCRP FLEX REAGENT CARTRIDGE |
| Classification | System, Test, C-reactive Protein |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | Lorraine H Pietrak |
| Correspondent | Lorraine H Pietrak DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-02 |
| Decision Date | 2001-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768014130 | K003419 | 000 |