IMMULITE 2000 THYROGLOBULIN MODEL L2KTY— 510(k) K982468
Substantially EquivalentDiagnostic Products Corp.
FDA 510(k) clearance K982468 for IMMULITE 2000 THYROGLOBULIN MODEL L2KTY, Substantially Equivalent on 1999-03-12. Applicant: Diagnostic Products Corp.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Products Corp.
- Product code
- Code MSW
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code MSW
view allMore clearances from Diagnostic Products Corp.
view all- K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
- K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
- 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 K982468
K-number listed on FDA's recall record- Z-0949-2023 — IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # L2KTY2(D) Siemens Material Number (SMN): 10381647
- Z-0950-2023 — IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KTY2 Siemens Material Number (SMN): 10381648
- Z-1685-2018 — IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982468.
Data sourced from openFDA. This site is unofficial and independent of the FDA.