Apo B Ria Kit

FDA 510(k) K851389 · Iso-Tex Diagnostics

Substantially Equivalent

510(k) numberK851389

Submission

Device name
Apo B Ria Kit
Applicant
Iso-Tex Diagnostics
Friendswood, TX, US
Received
April 9, 1985
Decision date
July 10, 1985
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
K840105Apo A-I Ria Kit-Human Plasma Apolip- · Traditional 01/10/1984SESP
K782081Ria System, Parathyroid HormoneCEW · Traditional 03/21/1979SE

Questions and answers

When was Apo B Ria Kit cleared by the FDA?

Apo B Ria Kit (K851389) received a 510(k) decision of Substantially Equivalent on July 10, 1985, 92 days after the submission was received.

What is the product code of K851389?

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