IMMILITE TOTAL IGE— 510(k) K960067

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K960067 for IMMILITE TOTAL IGE, Substantially Equivalent on 1996-02-14. Applicant: Diagnostic Products Corp.. Device class: 2.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code JHR
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1996-01-05
Decision date: 1996-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Diagnostic Products Corp.

Recalls naming K960067

K-number listed on FDA's recall record

Z-1517-2014 — IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.Class II·Terminated·Siemens Healthcare Diagnostics·20131220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960067.

Data sourced from openFDA. This site is unofficial and independent of the FDA.