TOPTOLIFE DIAGNOSTICS LLC

FDA Device Registration & Listing · Wilmington, DE, US · Registration 3042471840

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042471840
FEI Number
3042471840
Entity Name
TOPTOLIFE DIAGNOSTICS LLC
City/State/Country
Wilmington, DE, US
Establishment Address
4023 Kennett Pike #50076, Wilmington, DE 19807, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Toptolife Diagnostics LLC (Owner Number: 10094716)
Owner / Operator Contact Address
4023 Kennett Pike #50076, Wilmington, DE 19807, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K111999
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2025-12-18
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2025-12-18
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2026-01-23
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2026-01-23
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2026-01-23
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2026-01-23
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Clinical Chemistry Class 1 862.1095 2026-01-23
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2026-01-23
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2026-01-23
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2026-01-23
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2026-01-23
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2026-01-23
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2026-01-23
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2026-01-23

Official Correspondent

Airan Li

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Toptolife Diagnostics LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K162333 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step Fecal Occult Blood (FOB) Test 2017-05-14
K133343 Guangzhou Wondfo Biotech Co., Ltd. WONDFO RAPID STREP A TEST 2014-01-31
K885053 Biotrol, USA, Inc. BIOTROL URINE PROTEINS REAGENT 1989-01-30
K101852 Iris International Inc., A Division of Iris Iris I CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT 2011-03-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0081-2015 Siemens Healthcare Diagnostics, Inc 2
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015 Siemens Healthcare Diagnostics, Inc 2
External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015 Siemens Healthcare Diagnostics, Inc 2
External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.

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2435505 POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. CORTLANDT MANOR, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042471840. Last updated year: 2026. Please use registration number 3042471840 when referencing this establishment in official correspondence.
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