DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125— 510(k) K061839
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K061839 for DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125, Substantially Equivalent on 2006-08-29. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code CIG
view allMore clearances from Dade Behring, Inc.
view all- K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07
- K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
- K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
- K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
- K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
Data sourced from openFDA. This site is unofficial and independent of the FDA.