IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)— 510(k) K013134
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K013134 for IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS), Substantially Equivalent on 2001-10-15. Applicant: Diagnostic Products Corp.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Los Angeles, CA, US
Recent devices under product code DHB
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view all- K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
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- K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
- K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
- K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE
Recalls naming K013134
K-number listed on FDA's recall record- Z-1674-2018 — IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
- Z-1843-2015 — IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013134.
Data sourced from openFDA. This site is unofficial and independent of the FDA.