LOCI 8 CALIBRATOR, MODEL KC 646— 510(k) K101460
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K101460 for LOCI 8 CALIBRATOR, MODEL KC 646, Substantially Equivalent on 2010-07-09. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Newark, DE, US
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Recalls naming K101460
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 K101460.
Data sourced from openFDA. This site is unofficial and independent of the FDA.