ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770— 510(k) K093732
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K093732 for ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770, Substantially Equivalent on 2010-03-22. 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
- Tarrytown, NY, US
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More clearances from Siemens Healthcare Diagnostics
view all- K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more
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Recalls naming K093732
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 K093732.
Data sourced from openFDA. This site is unofficial and independent of the FDA.