Imx Homocysteine

Q: When was Imx Homocysteine cleared by the FDA?

Imx Homocysteine (K980812) received a 510(k) decision of Substantially Equivalent on October 1, 1998, 212 days after the submission was received.

Q: What is the product code of K980812?

The FDA product code is DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5600.

FDA 510(k) K980812 · Axis Biochemicals, Asa

Substantially Equivalent

510(k) numberK980812

Submission

Device name: Imx Homocysteine
Applicant: Axis Biochemicals, Asa
San Diego, CA, US
Received: March 3, 1998
Decision date: October 1, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5600
Specialty: Immunology

Other 510(k)s with product code DFC

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K253069	Lipoprotein (a) Molarity AssayDFC · Traditional	Diazyme Laboratories, Inc.	06/16/2026SE
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K211058	Lp(a) UltraDFC · Traditional	SENTINEL CH. SpA	12/22/2022SE
K180074	Diazyme Lipoprotein (a) AssayDFC · Traditional	Diazyme Laboratories, Inc.	03/22/2018SE
K123046	Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) CalibratorDFC · Traditional	Siemens Healthcare Diagnostics, Inc.	12/20/2012SE
K122722	Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…DFC · Traditional	Roche Diagnostics	11/29/2012SE
K082488	Diazyme Lp(A) AssayDFC · Traditional	General Atomics	01/13/2009SE
K063838	Lipoprotein(A), Lipoprotein(A) Calibrator, Lipoprotein (a) Control, Control HighDFC · Traditional	Thermo Electron OY	09/27/2007SE
K050487	Quantia La(A)DFC · Traditional	Biokit, S.A.	04/26/2005SE
K023853	K-Assay Lp(A) ControlsDFC · Traditional	Kamiya Biomedical Co.	12/13/2002SE

More from Kamiya Biomedical Co.

510(k)	Device	Decision
K992274	Modification to Imx HomocysteineLPS · Traditional	10/06/1999SE
K980907	Axis Homocysteine Enzyme ImmunoassayLPS · Traditional	10/16/1998SE

Questions and answers

When was Imx Homocysteine cleared by the FDA?

Imx Homocysteine (K980812) received a 510(k) decision of Substantially Equivalent on October 1, 1998, 212 days after the submission was received.

What is the product code of K980812?

The FDA product code is DFC – Lipoprotein, Low-Density, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5600.