# Qingdao Hightop Biotech Co., Ltd.

- Location (FDA's records): Qingdao, CN
- FDA decisions: 3 (2019–2024): 3 510(k) clearances
- Product codes: NFT (1), NGL (1), LCX (1)
- 510(k) review time since 2016: median 40 days, against 50 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guangzhou Wondfo Biotech Co., Ltd.: 2 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)

## Firms that cite its devices most
- Eterbio, Inc.: 1 (https://510kreport.com/company/eterbio)
- Nanjing Synthgene Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/nanjing-synthgene-medical-technology)

## Its most-cited devices
- K241969: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (2024), cited by 1
- K192123: HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream (2019), cited by 1

## Recent decisions
- K241969: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (Aug 14, 2024)
- K220685: HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx (May 5, 2022)
- K192123: HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream (Sep 5, 2019)

Source page: https://510kreport.com/company/qingdao-hightop-biotech