Affinity PRG

FDA 510(k) K920230 · Bd Becton Dickinson Vacutainer Systems Preanalytic

Substantially Equivalent

510(k) numberK920230

Submission

Device name
Affinity PRG
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cockeysville, MD, US
Received
January 17, 1992
Decision date
February 18, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JLS – Radioimmunoassay, Progesterone
Device class
Class I (low risk)
Regulation
21 CFR 862.1620
Specialty
Clinical Chemistry

Other 510(k)s with product code JLS

510(k)DeviceApplicantDecision
K040923Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaJLS · Traditional Ibl GmbH07/22/2004SE
K973898Progesterone ElisaJLS · Traditional Kmi Diagnostics, Inc.11/13/1997SE
K972133Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone…JLS · Traditional Johnson & Johnson Clinical Diagnostics, Inc.06/24/1997SE
K971725Opus ProgesteroneJLS · Traditional Behring Diagnostics, Inc.06/18/1997SE
K964841Elecsys Progesterone AssayJLS · Traditional Boehringer Mannheim Corp.03/24/1997SE
K965084Vidas Proesterone (PRG) (30 409)JLS · Traditional bioMerieux, Inc.01/09/1997SE
K955025Axsym ProgesteroneJLS · Traditional Abbott Laboratories03/07/1996SE
K955769Access Progesterone AssayJLS · Traditional Bio-Rad Laboratories, Inc.02/05/1996SE
K952075Progesterone Assay for the Technicon Immuno 1 System In-Bitro Diagnostic SystemJLS · Traditional Bayer Corp.06/13/1995SE
K951630Auraflex Progesterone 150TEST PackJLS · Traditional Organon Teknika Corp.05/08/1995SE

More from Organon Teknika Corp.

510(k)DeviceDecision
K003062Bactec Mgit 960 Sir KitsMJA · Traditional 06/06/2001SE
K0035530.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional 03/21/2001SE
K003461BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional 02/01/2001SE
K002938B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional 11/29/2000SE
K001364BD Directigen Flu A+BPSZ · Traditional 06/28/2000SE
K000762Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional 04/25/2000SE
K000829Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional 04/13/2000SE
K993186Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional 11/03/1999SE
K992734Becton Dickinson SyringeMEG · Traditional 10/01/1999SE
K992849QBC Star Centrifugal Hematology SystemGKZ · Special 09/23/1999SE

Questions and answers

When was Affinity PRG cleared by the FDA?

Affinity PRG (K920230) received a 510(k) decision of Substantially Equivalent on February 18, 1992, 32 days after the submission was received.

What is the product code of K920230?

The FDA product code is JLS – Radioimmunoassay, Progesterone, a Class I (low risk) device regulated under 21 CFR 862.1620.