DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692— 510(k) K081643
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K081643 for DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692, Substantially Equivalent on 2008-07-03. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code MMI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newark, DE, US
Recent devices under product code MMI
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view all- K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more
- K162977 — ADVIA 2120i, ADVIA 2120
- K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL
- K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
- K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
Adverse events under product code MMI
product code MMI- Injury
- 172
- Malfunction
- 3,762
- Total
- 3,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K081643
K-number listed on FDA's recall record- Z-2436-2018 — Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
- Z-2606-2017 — Dimension Troponin 1 (TNI) Flex reagent cartridge
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081643.
Data sourced from openFDA. This site is unofficial and independent of the FDA.