The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Psa Flex Reagent Cartridge.
| Device ID | K003963 |
| 510k Number | K003963 |
| Device Name: | DIMENSION PSA FLEX REAGENT CARTRIDGE |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | George M Plummer |
| Correspondent | George M Plummer DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-22 |
| Decision Date | 2001-02-28 |