ELECSYS PRECICONTROL VARIA 3— 510(k) K111506
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K111506 for ELECSYS PRECICONTROL VARIA 3, Substantially Equivalent on 2011-07-08. Applicant: Roche Diagnostics. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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- K150300 — Liquichek Cardiac Markers Plus Control LT
More clearances from Roche Diagnostics
view allRecalls naming K111506
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111506.
Data sourced from openFDA. This site is unofficial and independent of the FDA.