Data / Medical devices / France / VitalScientific

VitalScientific: FDA-registered device maker in SEES Normandie, France, 33 510(k) clearances

Name: VitalScientific FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

VitalScientific is registered with the FDA (registration 3007662974) in SEES Normandie, France. It lists 37 device types. The FDA files 33 510(k) clearances under its listings, the newest dated July 11, 2017. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007662974
Address: Zone Industrielle 13 rue Auguste Mottin, SEES Normandie, France, 61500
Owner or operator: VitalScientific (10090892)
Roles: Manufacturer, Repackager or relabeler
First device listed: May 29, 2024
Registered through: 2026
Brand names listed: ALP IFCC SL, 8 x 12.5 mL, REF PISL-0210-NA, ALT/GPT 4+1 SL, 8 x 25 mL, REF ALSL-0250-NA, AST/GOT 4+1 SL, AST/GOT 4+1 SL, Ref.ASSL-0250, Acid Solution, Albumin, 12 x 20 mL, REF ALBU-0250-NA, Amylase SL, 6 x 20 mL, REF AMSL-0230-NA, BILIRUBIN DIRECT 4+1, REF BIDI-0250 and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Uric, Uricase (Colorimetric)	KNK	1	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Assay, Glycosylated Hemoglobin	LCP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Manufacturer	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Manufacturer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer	accessdata.fda.gov
Catalytic Methods, Amylase	JFJ	2	Manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Manufacturer	accessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Selective (Non-Specified)	JJP	1	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Manufacturer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Manufacturer	accessdata.fda.gov
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Manufacturer	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Manufacturer	accessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, Lipase	CHI	1	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Manufacturer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Manufacturer	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Manufacturer	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Manufacturer	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Manufacturer	accessdata.fda.gov
U.V. Method, Cpk Isoenzymes	JHW	2	Manufacturer	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 11, 2017	K171401	ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1	CIG	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
September 7, 2016	K153644	ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II	CFR	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
July 22, 2015	K151113	ELITech Clinical Systems CALCIUM ARSENAZO	CJY	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
July 18, 2014	K141265	ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT	JHW	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
January 3, 2014	K132399	ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL	JFY	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
February 15, 2013	K122177	ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL	JIT	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
October 3, 2012	K122858	ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II	JFJ	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
August 22, 2012	K122083	ELITECH CLINICAL SYSTEMS CK NAC SL	JHW	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
December 29, 2011	K113269	ELITTECH CLINICAL SYSTEMS ALP IFCC SL	CJE	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
November 18, 2011	K111960	ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS	KHS	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
November 18, 2011	K103376	ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL	JFY	Substantially Equivalent	Seppim S.A.S.	accessdata.fda.gov
October 7, 2011	K110780	ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II	CIG	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
September 14, 2011	K111996	ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2	JJY	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
August 31, 2011	K103747	ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS	LBS	Substantially Equivalent	Elitechgroup Seppim S.A.S.	accessdata.fda.gov
June 28, 2011	K111063	VITAL SERUM CONTROLS	JJY	Substantially Equivalent	Vital Diagnostics (Manufacturing) Ptyltd	accessdata.fda.gov
June 21, 2011	K110830	ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH	CIX	Substantially Equivalent	Elitechgroup	accessdata.fda.gov
June 9, 2011	K110394	ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)	JIX	Substantially Equivalent	Vital Diagnostics (Manufacturing) Ptyltd	accessdata.fda.gov
May 19, 2011	K102993	ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL	CDT	Substantially Equivalent	Seppim S.A.S.	accessdata.fda.gov
May 19, 2011	K100547	ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL	LCP	Substantially Equivalent	Seppim S.A.S.	accessdata.fda.gov
May 6, 2011	K100263	ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS	CEO	Substantially Equivalent	Seppim S.A.S.	accessdata.fda.gov
March 24, 2011	K102647	ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...	JGS	Substantially Equivalent	Elitechgroup Vital Scientific BV	accessdata.fda.gov
December 15, 2010	K100525	ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2	CGA	Substantially Equivalent	Seppim S.A.S.	accessdata.fda.gov
September 20, 2010	K093883	AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-	CIT	Substantially Equivalent	Seppim S.A.S.	accessdata.fda.gov
December 20, 2007	K071706	ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)	LBS	Substantially Equivalent	Clinical Data, Inc.	accessdata.fda.gov
May 21, 2004	K033983	VITALAB IRON REAGENT	JIY	Substantially Equivalent	Clinical Data, Inc.	accessdata.fda.gov
March 18, 2004	K040631	VITALAB DIRECT BILIRUBIN REAGENT	CIG	Substantially Equivalent	Clinical Data, Inc.	accessdata.fda.gov
March 8, 2004	K040508	VITALAB MAGNESIUM REAGENT	JGJ	Substantially Equivalent	Clinical Data, Inc.	accessdata.fda.gov
March 8, 2004	K040467	VITALAB URIC ACID REAGENT	KNK	Substantially Equivalent	Clinical Data, Inc.	accessdata.fda.gov
August 6, 2003	K031539	HEMOGLOBIN A1C REAGENT SET	LCP	Substantially Equivalent	Pointe Scientific, Inc.,	accessdata.fda.gov
April 12, 2002	K020575	ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS	MRR	Substantially Equivalent	Elan Diagnostics	accessdata.fda.gov
April 9, 2001	K010488	ATAC PAK AST REAGENT KIT	CIT	Substantially Equivalent	Elan Holdings, Inc.	accessdata.fda.gov
September 26, 2000	K002285	ATAC PAK ALP REAGENT KIT	CJE	Substantially Equivalent	Elan Diagnostics	accessdata.fda.gov
April 20, 1995	K945271	ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM	JJE	Substantially Equivalent	Bio-Chem Laboratory Systems, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 18, 2017	80321	Class II	Terminated	ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117	ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has result	accessdata.fda.gov
September 22, 2015	72322	Class II	Terminated	Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Choleste	ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.	accessdata.fda.gov
August 11, 2014	69024	Class III	Terminated	ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in	Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.	accessdata.fda.gov
September 4, 2013	66331	Class II	Terminated	Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL,. C	Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.	accessdata.fda.gov

Compare with other makers

Updated July 11, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.