K-ASSAY MULTI-ANALYTE CALIBRATOR— 510(k) K993853
Substantially EquivalentKamiya Biomedical Co.
FDA 510(k) clearance K993853 for K-ASSAY MULTI-ANALYTE CALIBRATOR, Substantially Equivalent on 1999-12-27. Applicant: Kamiya Biomedical Co.. Device class: 2.
Clearance details
- Applicant
- Kamiya Biomedical Co.
- 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
- Traditional
- Location
- Seattle, WA, US
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More clearances from Kamiya Biomedical Co.
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- K050944 — K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
- K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
- K030687 — K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
Recalls naming K993853
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 K993853.
Data sourced from openFDA. This site is unofficial and independent of the FDA.