ADVIA CHEMISTRY SALICYLATE REAGENT— 510(k) K093939
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K093939 for ADVIA CHEMISTRY SALICYLATE REAGENT, Substantially Equivalent on 2010-05-19. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code DKJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3830
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code DKJ
view all- K042329 — SALICYLATE-SL ASSAY
- K020794 — SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K014173 — SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
- K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
- K981872 — SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
More clearances from Siemens Healthcare Diagnostics
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
Recalls naming K093939
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 K093939.
Data sourced from openFDA. This site is unofficial and independent of the FDA.