Dimensions Pbnp Flex Reagent Cartridge, Model RF423A
by Dade Behring, Inc. 510(k)
Active
510(k) K071767
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071767 | Date4 Aug 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 11 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NBC
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1117
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent