Apo B., Immunoturbidimetric Assay

FDA 510(k) K864228 · Intl. Diagnostic Laboratories, Ltd.

Substantially Equivalent

510(k) numberK864228

Submission

Device name
Apo B., Immunoturbidimetric Assay
Applicant
Intl. Diagnostic Laboratories, Ltd.
Israel, IL
Received
October 28, 1986
Decision date
March 12, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MSJ – Apolipoproteins
Device class
Class I (low risk)
Regulation
21 CFR 862.1475
Specialty
Clinical Chemistry

Other 510(k)s with product code MSJ

510(k)DeviceApplicantDecision
K072977Diazyme Apolipoprotein A-1 AssayMSJ · Traditional General Atomics07/16/2008SE
K073488Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model DzxxxMSJ · Traditional Diazyme Laboratories03/07/2008SE
K061377Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional Pointe Scientific, Inc.,03/28/2007SE
K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…MSJ · Traditional Dade Behring, Inc.02/23/2007SE
K9926628 Additional Assays for the Bayer Advia 1650 Chemistry SystemMSJ · Traditional Bayer Corp.02/15/2000SE
K970314Synchron LX Systems Apolipoprotein (Apoa and Apob) ReagentsMSJ · Traditional Beckman Instruments, Inc.04/21/1997SE
K964010Immage Immunochemistry System Apolipoprotein A-1 Reagent (Apa)/ Immage Immunochemistry…MSJ · Traditional Beckman Instruments, Inc.02/10/1997SE
K931777Apo A-1 Chemiluminescence AssayMSJ · Traditional Nichols Institute08/16/1993SE
K925702Nichols Apo B Chemiluminescence AssayMSJ · Traditional Nichols Institute Diagnostics12/23/1992SE
K923087Il Test Apolipoprotein A1MSJ · Traditional Instrumentation Laboratory CO10/26/1992SE

More from Instrumentation Laboratory CO

510(k)DeviceDecision
K864811Rota-StatLIQ · Traditional 08/25/1987SE
K864393Apolipoprotein A1 (Apo A1) ImmunoturbidimetricMSJ · Traditional 01/16/1987SE
K843367Rotavirus Enzyme ImmunoassayLIQ · Traditional 06/13/1985SE

Questions and answers

When was Apo B., Immunoturbidimetric Assay cleared by the FDA?

Apo B., Immunoturbidimetric Assay (K864228) received a 510(k) decision of Substantially Equivalent on March 12, 1987, 135 days after the submission was received.

What is the product code of K864228?

The FDA product code is MSJ – Apolipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.