N LATEX CDT— 510(k) K060677
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K060677 for N LATEX CDT, Substantially Equivalent on 2006-08-25. Applicant: Dade Behring, Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code NAO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1360
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code NAO
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- K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
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- K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
Recalls naming K060677
K-number listed on FDA's recall record- Z-1790-2020 — Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
- Z-2931-2018 — N Latex CDT Kit
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060677.
Data sourced from openFDA. This site is unofficial and independent of the FDA.