ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP— 510(k) K081338
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K081338 for ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP, Substantially Equivalent on 2008-09-11. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code NHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code NHX
view all- K153551 — ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
- K143754 — QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
- K121576 — IMMULITE 2000 ANTI-CCP IGG ASSAY
- K112810 — MULTI-ANALYTE DETECTION SYSTEMS
- K110296 — AXIS-SHIELD ANTI-CCP
More clearances from Roche Diagnostics
view allRecalls naming K081338
K-number listed on FDA's recall record- Z-2361-2019 — Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
- Z-2362-2019 — Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081338.
Data sourced from openFDA. This site is unofficial and independent of the FDA.