IMMULITE CORTISOL— 510(k) K931409

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K931409 for IMMULITE CORTISOL, Substantially Equivalent on 1993-05-11. Applicant: Diagnostic Products Corp.. Device class: 2.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1993-03-19
Decision date: 1993-05-11
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 K931409

K-number listed on FDA's recall record

Z-0122-2015 — IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.Class II·Terminated·Siemens Healthcare Diagnostics·20140919

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K931409.

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