Data / Medical devices / United States / Clarity Diagnostics, LLC

Clarity Diagnostics, LLC: FDA-registered device maker in Deerfield Bch, FL, United States, 7 510(k) clearances

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

Clarity Diagnostics, LLC is registered with the FDA (registration 3004043187) in Deerfield Bch, FL, United States. It lists 18 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 5, 2006. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004043187
Address: 1701 Green Rd Ste A, Deerfield Bch, FL, United States, 33064
Owner or operator: Clarity Diagnostics (9057600)
Roles: Complaint file establishment
First device listed: July 24, 2003
Registered through: 2026
Brand names listed: Clarity Glucose Meter, Clarity Mononucleosis Test, Clarity Rapid Strep A test, Clarity Urine HCG Pregnancy Tests, Clarity Urine Pregnancy Tests, Clarity Urocheck Urine Strips

Devices it lists

Device	Product code	Class	Role	Source
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	1	Complaint file establishment	accessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.	GTY	1	Complaint file establishment	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Complaint file establishment	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Complaint file establishment	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Complaint file establishment	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Complaint file establishment	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Complaint file establishment	accessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	1	Complaint file establishment	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Complaint file establishment	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Complaint file establishment	accessdata.fda.gov
Kit, Screening, Urine	JXA	1	Complaint file establishment	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Complaint file establishment	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Complaint file establishment	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Complaint file establishment	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Complaint file establishment	accessdata.fda.gov
System, Test, Infectious Mononucleosis	KTN	2	Complaint file establishment	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Complaint file establishment	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Complaint file establishment	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
December 5, 2006	K052719	URITEST 10 URINALYSIS REAGENT STRIPS	CDM	Substantially Equivalent	Arj Medical, Inc.	accessdata.fda.gov
October 10, 2006	K062829	DIACHEX BLOOD GLUCOSE MONITORING SYSTEM	NBW	Substantially Equivalent	Tyson Bioresearch, Inc.	accessdata.fda.gov
August 11, 2006	K061559	ACON URINALYSIS REAGENT STRIPS	CDM	Substantially Equivalent	Acon Laboratories Co.	accessdata.fda.gov
February 28, 2005	K042272	ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)	KTN	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
February 10, 2003	K023766	ACON STREP A TWIST TEST DEVICE	GTY	Substantially Equivalent	Acon Laboratories Co.	accessdata.fda.gov
May 23, 2002	K020439	STATUS HCG SERUM/URINE	JHI	Substantially Equivalent	Princeton BioMeditech Corp.	accessdata.fda.gov
October 3, 1995	K951705	MINISTRIP HCG	JHI	Substantially Equivalent	International Newtech Development, 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
June 22, 2018	80535	Class III	Terminated	Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose,	Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.	accessdata.fda.gov

Compare with other makers

Updated July 24, 2018. 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.