DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B— 510(k) K073072
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K073072 for DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B, Substantially Equivalent on 2008-02-21. Applicant: Dade Behring, Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code JHM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- P.O. Box 6101, Newark, DE, US
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More 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
Recalls naming K073072
K-number listed on FDA's recall record- Z-1659-2016 — Dimension Assays: Direct HDL Cholesterol (AHDL)
- Z-1663-2016 — Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073072.
Data sourced from openFDA. This site is unofficial and independent of the FDA.