Uc Imu B

FDA 510(k) K904137 · Eucardio Laboratory, Inc.

Substantially Equivalent

510(k) numberK904137

Submission

Device name
Uc Imu B
Applicant
Eucardio Laboratory, Inc.
San Diego, CA, US
Received
September 6, 1990
Decision date
November 21, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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K211058Lp(a) UltraDFC · Traditional SENTINEL CH. SpA12/22/2022SE
K180074Diazyme Lipoprotein (a) AssayDFC · Traditional Diazyme Laboratories, Inc.03/22/2018SE
K123046Advia Chemistry Lipoprotein(A) Reagent Advia Chemistry Lipoprotein(A) CalibratorDFC · Traditional Siemens Healthcare Diagnostics, Inc.12/20/2012SE
K122722Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…DFC · Traditional Roche Diagnostics11/29/2012SE
K082488Diazyme Lp(A) AssayDFC · Traditional General Atomics01/13/2009SE
K063838Lipoprotein(A), Lipoprotein(A) Calibrator, Lipoprotein (a) Control, Control HighDFC · Traditional Thermo Electron OY09/27/2007SE
K050487Quantia La(A)DFC · Traditional Biokit, S.A.04/26/2005SE
K023853K-Assay Lp(A) ControlsDFC · Traditional Kamiya Biomedical Co.12/13/2002SE

More from Kamiya Biomedical Co.

510(k)DeviceDecision
K942464Uc Qik 1-STEP HCG TestJHI · Traditional 09/20/1994SE
K926500Uc Qik Pregnancy TestJHI · Traditional 06/07/1993SE
K904125Uc Imu aDER · Traditional 09/24/1990SE

Questions and answers

When was Uc Imu B cleared by the FDA?

Uc Imu B (K904137) received a 510(k) decision of Substantially Equivalent on November 21, 1990, 76 days after the submission was received.

What is the product code of K904137?

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