Acon Biotech (Hangzhou) Co., Ltd.
Hangzhou Zhejiang, CN
ACON BIOTECH (HANGZHOU) CO., LTD. appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615507 | 3002829675 | ACON BIOTECH (HANGZHOU) CO., LTD. | No. 210 Zhenzhong Road, HANGZHOU Zhejiang 310030 CN | 2026 | and 19 more, listed in full below |
| 3032171519 | 3032171519 | Acon Biotech (Hangzhou) Co., Ltd. | Building 3 and Building 11, No. 33 Shidi Street, Qingshanhu Subdistrict, Linan District, Hangzhou Zhejiang 311305 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JQPCalculator/Data Processing Module, For Clinical Use
- JGYColorimetric Method, Triglycerides
- GGMControl, Hemoglobin
- QMNCovid-19 Multi-Analyte Antigen Device
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- CGAGlucose Oxidase, Glucose
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- LBRLdl & Vldl Precipitation, Hdl
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- QYTOver-The-Counter Covid-19 Antigen Test
- JRERefractometer For Clinical Use
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- GKRSystem, Hemoglobin, Automated
- NBWSystem, Test, Blood Glucose, Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- NGJTest, Nitrite, Urinary, Non-Quantitative, Over The Counter
- LJXTest, Urine Leukocyte
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0945-2022 | Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked | Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain