Iso-Sep System

FDA 510(k) K831434 · Berwick Medical Products, Inc.

Substantially Equivalent

510(k) numberK831434

Submission

Device name
Iso-Sep System
Applicant
Berwick Medical Products, Inc.
Mchenry, IL, US
Received
May 4, 1983
Decision date
June 30, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CDP – Radioimmunoassay, Total Triiodothyronine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1710
Specialty
Clinical Chemistry

Other 510(k)s with product code CDP

510(k)DeviceApplicantDecision
K001607Reprobead T3 Enzyme Immunoassay Reagent Kit (Catalog# 104)CDP · Traditional Repromedix Corp.10/05/2000SE
K991692Chiron Diagnostics Acs: 180 FT3CDP · Traditional Chiron Diagnostics Corp.06/18/1999SE
K991311Total T3 Enzyme Immunoassay Test Kit, Model BC-1005CDP · Traditional Biocheck, Inc.06/02/1999SE
K991252Aia-Pack FT3 AssayCDP · Traditional Tosoh Medics, Inc.05/11/1999SE
K981824Opticoat T3 Eia KitCDP · Traditional Biotecx Laboratories, Inc.12/22/1998SE
K983439Abbott Architect Free T3CDP · Traditional Abbott Laboratories11/20/1998SE
K983434Abbott Architect Total T3CDP · Traditional Abbott Laboratories11/20/1998SE
K974027Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator PackCDP · Traditional Alfa Biotech (Uk) , Ltd.02/02/1998SE
K974634Immulite Free T3CDP · Traditional Diagnostic Products Corp.01/02/1998SE
K973966Access Total T3 Reagents on the Access Immunoassay AnalyzerCDP · Traditional Beckman Instruments, Inc.10/31/1997SE

More from Beckman Instruments, Inc.

510(k)DeviceDecision
K850800Dropstirs - Plastic Disposable PipetJQW · Traditional 04/02/1985SE
K842018Iso-Sep SystemCEX · Traditional 09/28/1984SE
K831289Prefilled Iec ColumnsDJY · Traditional 06/16/1983SE
K830918I.E.C ColumnKEA · Traditional 04/27/1983SE

Questions and answers

When was Iso-Sep System cleared by the FDA?

Iso-Sep System (K831434) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 57 days after the submission was received.

What is the product code of K831434?

The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.