Data / Medical devices / United Kingdom / RSR Ltd.

RSR Ltd.: FDA-registered device maker in Cardiff, United Kingdom, 18 510(k) clearances

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

RSR Ltd. is registered with the FDA (registration 3003834021) in Cardiff, United Kingdom. It lists 9 device types. The FDA files 18 510(k) clearances under its listings, the newest dated August 24, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003834021
FEI number: 3002808039
Address: Parc Ty Glas Llanishen, Cardiff, United Kingdom, CF14 5DU
Owner or operator: RSR Limited (10023525)
Roles: Manufacturer
First device listed: November 29, 2007
Registered through: 2026
Brand names listed: 125-I TSH RECEPTOR ANTIBODY KIT, ANTI-THYROGLOBULIN TEST KIT, KONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT, KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay, KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT, KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT, KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT, KRONUS IA-2 AUTOANTIBODY (IA-2Ab) ELISA KIT and more

Devices it lists

Device	Product code	Class	Role	Source
21-Hydroxylase Antibody (21-Ohab)	PCG	2	Manufacturer	accessdata.fda.gov
Aquaporin-4 Autoantibody	PNI	2	Manufacturer	accessdata.fda.gov
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking	NST	2	Manufacturer	accessdata.fda.gov
Autoantibodies, Glutamic Acid Decarboxylase (Gad)	NWG	2	Manufacturer	accessdata.fda.gov
Insulin Autoantibody Kit	OCN	2	Manufacturer	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Manufacturer	accessdata.fda.gov
Tyrosine Phosphatase (Ia-2) Autoantibody Assay	OIF	2	Manufacturer	accessdata.fda.gov
Voltage Gated Calcium Channel (Vgcc) Antibody Assay	PAF	2	Manufacturer	accessdata.fda.gov
Zinc Transporter 8 Auto-Antibody	PHF	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
August 24, 2023	K220085	KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit	OIF	Substantially Equivalent	Kronus, Inc.	accessdata.fda.gov
November 23, 2018	K180607	Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit	PCG	Substantially Equivalent	Kronus, Inc.	accessdata.fda.gov
January 19, 2018	K171731	KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit	OIF	Substantially Equivalent	Kronus, Inc.	accessdata.fda.gov
July 22, 2016	K161951	KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay	PNI	Substantially Equivalent	Kronus, Inc.	accessdata.fda.gov
August 20, 2014	DEN140001	ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT	PHF	Unknown	Kronus Market Development Associates, Inc.	accessdata.fda.gov
December 20, 2012	K121046	STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT	PCG	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
May 30, 2012	K111956	KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT	PAF	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
June 17, 2008	K080523	KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT	NST	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
May 22, 2008	K080159	KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT	JZO	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
April 10, 2008	K073590	KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT	OIF	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
November 7, 2007	K072135	KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT	NWG	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
July 13, 2007	K070183	KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT	OCN	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
November 4, 2005	K051061	KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT	NWG	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
December 17, 2004	K042248	KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT	NST	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
September 10, 2003	K032134	TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT	JZO	Substantially Equivalent	Kronus Market Development Associates, Inc.	accessdata.fda.gov
July 25, 1989	K894364	MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)	JZO	Substantially Equivalent	Kronus	accessdata.fda.gov
July 25, 1989	K894203	ANTI-THYROGLOBULIN TEST KIT	JZO	Substantially Equivalent	Kronus	accessdata.fda.gov
September 8, 1986	K863006	125-I TSH RECEPTOR ANTIBODY KIT	JZO	Substantially Equivalent	Cronus	accessdata.fda.gov

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Updated August 24, 2023. 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.