FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM— 510(k) K994419

Name: FDA 510(k) clearance K994419
Creator: U.S. Food and Drug Administration
Published: 2000-06-28

Substantially Equivalent

Qualisys Diagnostics, Inc.

FDA 510(k) clearance K994419 for FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM, Substantially Equivalent on 2000-06-28. Applicant: Qualisys Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Qualisys Diagnostics, Inc.
Product code: Code LTJ
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1999-12-29
Decision date: 2000-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K994419

K-number listed on FDA's recall record

Z-0547-2014 — FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.Class II·Terminated·Qualigen Inc·20131108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994419.

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