QC3 Whole Human Serum, Hdl-Cholesterol Control

FDA 510(k) K872078 · Solomon Park Research Laboratories

Substantially Equivalent

510(k) numberK872078

Submission

Device name
QC3 Whole Human Serum, Hdl-Cholesterol Control
Applicant
Solomon Park Research Laboratories
Kirkland, WA, US
Received
May 29, 1987
Decision date
June 18, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DER – Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5580
Specialty
Immunology

Other 510(k)s with product code DER

510(k)DeviceApplicantDecision
K013249Tina-Quant Apolipoprotein VER.2DER · Traditional Roche Diagnostics Corp.11/16/2001SE
K000921Bayer Advia Ims System; 200 + 3DER · Traditional Bayer Corp.05/18/2000SE
K993354K-Assay Apo BDER · Traditional Kamiya Biomedical Co.10/28/1999SE
K993345K-Assay Apo AiDER · Traditional Kamiya Biomedical Co.10/25/1999SE
K990594Integra Reagent Cassette for Apolipoprotein A-1DER · Traditional Roche Diagnostics Corp.04/14/1999SE
K983289Apolipoprotein A1DER · Traditional Abbott Laboratories01/29/1999SE
K964296N-Assay Tia Apo B Test KitDER · Traditional Crestat Diagnostics, Inc.08/01/1997SE
K964294N-Assay Tia Apo A1/B Multi CalibratorDER · Traditional Crestat Diagnostics, Inc.08/01/1997SE
K964292N-Assay Tia Apo A1 Test KitDER · Traditional Crestat Diagnostics, Inc.08/01/1997SE
K910553Roche Apolipoprotein StandardDER · Traditional Roche Diagnostic Systems, Inc.05/08/1991SE

Questions and answers

When was QC3 Whole Human Serum, Hdl-Cholesterol Control cleared by the FDA?

QC3 Whole Human Serum, Hdl-Cholesterol Control (K872078) received a 510(k) decision of Substantially Equivalent on June 18, 1987, 20 days after the submission was received.

What is the product code of K872078?

The FDA product code is DER – Alpha-1-Lipoprotein, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5580.