Toa Medical Electronics CA-5000

Q: What is the product code of K942097?

The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.

FDA 510(k) K942097 · Sysmex Corp.

Substantially Equivalent

510(k) numberK942097

Submission

Device name: Toa Medical Electronics CA-5000
Applicant: Sysmex Corp.
Los Alamitos, CA, US
Received: April 14, 1994
Decision date: March 24, 1995
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JPA – System, Multipurpose For In Vitro Coagulation Studies
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.5425
Specialty: Hematology

Other 510(k)s with product code JPA

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K253658	STA Satellite Max®JPA · Traditional	Diagnostica Stago, Inc.	04/27/2026SE
K250965	Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA · Traditional	Sysmex America, Inc.	06/02/2025SE
K251024	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special	Haemonetics	04/30/2025SE
K243858	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special	Haemonetics Corporation	01/15/2025SE
K232018	Citrated: K, KH, RTH, FFHJPA · Traditional	Haemonetics Corporation	03/29/2024SE
K233790	Acl Top 970 CLJPA · Special	Instrumentation Laboratory	12/29/2023SE
K221359	ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional	Instrumentation Laboratory CO	09/29/2023SE
K212183	STA R Max 3, STA Compact Max 3JPA · Traditional	Diagnostica Stago S.A.S	06/07/2023SE
K201440	ROTEM sigma Thromboelastometry SystemJPA · Traditional	Tem Innovations GmbH	07/08/2022SE
K202101	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…JPA · Traditional	Accriva Diagnostics, Inc.	12/29/2021SE

More from Accriva Diagnostics, Inc.

510(k)	Device	Decision
K012372	Sysmex UF-50LKM · Traditional	09/28/2001SE
K992875	Sysmex XE-2100, Automatated Hematology AnalyzerGKZ · Traditional	11/09/1999SE
K981950	Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional	11/03/1998SE
K981761	Sysmex KX-21, Automated Hematology AnalyzerGKL · Traditional	08/14/1998SE
K971736	Sysmex Immature Reticulocyte Fraction (Irf) ParameterGKZ · Traditional	08/26/1997SE
K964946	Sysmex CA-1000/SYSMEX CA-5000JPA · Traditional	03/18/1997SE
K964375	Sysmex SE/RAM-1GKL · Traditional	03/13/1997SE
K961054	Sysmex UF-100LKM · Traditional	10/28/1996SE
K950508	Sysmex SF-3000FPK · Traditional	11/03/1995SE
K945837	Sysmex(Tm) F-820, 520GKZ · Traditional	06/09/1995SE

Questions and answers

When was Toa Medical Electronics CA-5000 cleared by the FDA?

Toa Medical Electronics CA-5000 (K942097) received a 510(k) decision of Substantially Equivalent on March 24, 1995, 344 days after the submission was received.

What is the product code of K942097?

The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.