My Allergy Test

Q: When was My Allergy Test cleared by the FDA?

My Allergy Test (K021698) received a 510(k) decision of Substantially Equivalent on September 19, 2002, 120 days after the submission was received.

Q: What is the product code of K021698?

The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.

FDA 510(k) K021698 · Immunetech Corporation

Substantially Equivalent

510(k) numberK021698

Submission

Device name: My Allergy Test
Applicant: Immunetech Corporation
Rancho Santa Fe, CA, US
Received: May 22, 2002
Decision date: September 19, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1675
Specialty: Clinical Chemistry

Other 510(k)s with product code JKA

510(k)	Device	Applicant	Decision
K252899	Female Culture Device; Male Culture Device; Transfer Device; Access DeviceJKA · Traditional	Zhejiang Kindly Medical Device Co., Ltd.	06/02/2026SE
K260128	BD Preset and BD A-Line Arterial Blood Collection SyringesJKA · Special	Becton, Dickinson and Company	04/15/2026SE
K252506	BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood…JKA · Traditional	Becton, Dickinson and Company	04/10/2026SE
K252378	BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood…JKA · Traditional	Becton, Dickinson and Company	04/10/2026SE
K252040	BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood…JKA · Traditional	Becton, Dickinson and Company	03/13/2026SE
K251812	Steripath® Flow Blood Collection SystemJKA · Traditional	Magnolia Medical Technologies	09/25/2025SE
K243207	BD Vacutainer® Eclipse Blood Collection NeedleJKA · Traditional	Becton, Dickinson and Company	07/03/2025SE
K250961	Blood collection tube holdersJKA · Traditional	Promisemed Hangzhou Meditech Co., Ltd.	06/04/2025SE
K244047	Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)JKA · Traditional	Venocare, Inc.	05/23/2025SE
K250907	Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special	Sol-Millennium Medical, Inc.	04/30/2025SE

More from Sol-Millennium Medical, Inc.

510(k)	Device	Decision
K061979	Modification to Myallergy TestJKA · Special	09/22/2006SE
K032251	Immunetech Total Ige SystemDGC · Traditional	12/19/2003SE
K020387	Myallergytest SystemDHB · Traditional	04/17/2002SE

Questions and answers

When was My Allergy Test cleared by the FDA?

My Allergy Test (K021698) received a 510(k) decision of Substantially Equivalent on September 19, 2002, 120 days after the submission was received.

What is the product code of K021698?

The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.