510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241969Substantially Equivalent

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

Qingdao Hightop Biotech Co., Ltd., Qingdao, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241969 is the FDA 510(k) clearance record for Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel, a class II device, cleared for Qingdao Hightop Biotech Co., Ltd. on under FDA product code NGL (Test, Opiates, Over The Counter). FDA records list 3 510(k) clearances for Qingdao Hightop Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K241969.

Clearance record

Decision date
Received
(40 days to decision)
Product code
NGL Test, Opiates, Over The Counter
Regulation
21 CFR 862.3650
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Qingdao Hightop Biotech Co., Ltd. #369 Hedong Rd., Qingdao, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NGL

Trailing 12 months
1 clearance under product code NGL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NGL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260