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Toptolife Diagnostics LLC: FDA-registered device maker in Wilmington, DE, United States, 4 510(k) clearances

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

Toptolife Diagnostics LLC is registered with the FDA (registration 3042471840) in Wilmington, DE, United States. It lists 15 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 14, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3042471840
Address: 4023 Kennett Pike #50076, Wilmington, DE, United States, 19807
Owner or operator: Toptolife Diagnostics LLC (10094716)
Roles: Repackager or relabeler
First device listed: December 18, 2025
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	1	Repackager or relabeler	accessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.	GTY	1	Repackager or relabeler	accessdata.fda.gov
Automated Urinalysis System	KQO	1	Repackager or relabeler	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Repackager or relabeler	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Repackager or relabeler	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Repackager or relabeler	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Repackager or relabeler	accessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	1	Repackager or relabeler	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Repackager or relabeler	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Repackager or relabeler	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Repackager or relabeler	accessdata.fda.gov
Reagent, Occult Blood	KHE	2	Repackager or relabeler	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Repackager or relabeler	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Repackager or relabeler	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Repackager or relabeler	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
May 14, 2017	K162333	Wondfo One Step Fecal Occult Blood (FOB) Test	KHE	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
January 31, 2014	K133343	WONDFO RAPID STREP A TEST	GTY	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
April 17, 2012	K111999	HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL	JIO	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
April 21, 2009	K072500	ONE STEP HCG URINE/SERUM TEST	DHA	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 14, 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.