Chrysalis Intelligence · Sponsors · Hangzhou AllTest Biotech Co., Ltd.

Hangzhou AllTest Biotech Co., Ltd.

Hangzhou, CN · 13 510(k) clearances

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Total clearances
13
2022-01-31 → 2026-04-30
Last 12 months
2
Product codes
9
Most recent
2026-04-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NFT Test, Amphetamine, Over The Counter Class II Clinical Toxicology 4 2025-04-04
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Class II Clinical Chemistry 2 2025-07-15
GTY — — — 1 2026-04-30
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Class I Clinical Chemistry 1 2025-10-30
JSM — — — 1 2025-04-04
DKZ — — — 1 2023-12-13
NGL Test, Opiates, Over The Counter Class II Clinical Toxicology 1 2023-10-26
DJG Enzyme Immunoassay, Opiates Class II Clinical Toxicology 1 2023-07-31
JHI Visual, Pregnancy Hcg, Prescription Use Class II Clinical Chemistry 1 2022-01-31
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2026-04-30 K260342 AllTest Strep A Rapid Test GTY — —
2025-10-30 K252607 AllTest Urinary Tract Infection Test JMT Class I Clinical Chemistry
2025-07-15 K251053 Shinetell PlusTM Digital Early Pregnancy Test LCX Class II Clinical Chemistry
2025-04-04 K250727 AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup NFT Class II Clinical Toxicology
2025-04-04 K242576 AllTest Viral Transport Medium JSM — —
2025-02-27 K244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup NFT Class II Clinical Toxicology
2024-09-27 K242540 AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel NFT Class II Clinical Toxicology
2024-08-13 K241978 Shinetell Digital Pregnancy Test LCX Class II Clinical Chemistry
2024-06-17 K241428 AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup NFT Class II Clinical Toxicology
2023-12-13 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx DKZ — —
2023-10-26 K233417 AllTest Fentanyl Urine Test Cassette NGL Class II Clinical Toxicology
2023-07-31 K231698 AllTest Fentanyl Rapid Test (Urine) DJG Class II Clinical Toxicology
2022-01-31 K203272 Alltest Pregnancy Rapid Combo Test Cassette JHI Class II Clinical Chemistry
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence