ELECSYS PRECICONTROL MULTIMARKER— 510(k) K102157
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K102157 for ELECSYS PRECICONTROL MULTIMARKER, Substantially Equivalent on 2010-08-27. 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
Recent devices under product code JJY
view all- K162530 — Multichem IA Plus
- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K150300 — Liquichek Cardiac Markers Plus Control LT
More clearances from Roche Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.