Qingdao Hightop Biotech Co., Ltd.
Qingdao Shandong, CN
QINGDAO HIGHTOP BIOTECH CO., LTD. appears in FDA device records in Qingdao Shandong, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Qingdao Hightop Biotech Co., Ltd. between 2019 and 2024. The busiest year on record is 2019, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel | NGL | Substantially Equivalent | |
| K220685 | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx | NFT | Substantially Equivalent | |
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream | LCX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014223276 | 3014223276 | QINGDAO HIGHTOP BIOTECH CO., LTD. | No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao Shandong 266112 CN | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LCMEnzyme Immunoassay, Phencyclidine
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- NFTTest, Amphetamine, Over The Counter
- PTHTest, Barbiturate, Over The Counter
- NFVTest, Benzodiazepine, Over The Counter
- NFWTest, Cannabinoid, Over The Counter
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- PTGTest, Methadone, Over The Counter
- NGGTest, Methamphetamine, Over The Counter
- NGLTest, Opiates, Over The Counter
- QBFTest, Propoxyphene, Over The Counter
- QAWTest, Tricyclic Antidepressants, Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain