IMMULITE SHBG (MODIFICATION)— 510(k) K955440

Name: FDA 510(k) clearance K955440
Creator: U.S. Food and Drug Administration
Published: 1995-12-21

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K955440 for IMMULITE SHBG (MODIFICATION), Substantially Equivalent on 1995-12-21. Applicant: Diagnostic Products Corp.. Device class: 1.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1995-10-23
Decision date: 1995-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDZ

view all

K252728 — IDS-iSYS Total Testosterone2026-04-15
K240865 — IDS-iSYS Free Testosterone2024-10-23
K233480 — Access SHBG2024-02-08
K223405 — Access Testosterone2023-01-13
K211685 — Elecsys Testosterone II2022-05-06

More clearances from Diagnostic Products Corp.

view all

Recalls naming K955440

K-number listed on FDA's recall record

Z-2166-2017 — SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20170131

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955440.

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