510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182654Substantially Equivalent

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

Safecare Biotech(hangzhou)co.,Ltd, Hangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182654 is the FDA 510(k) clearance record for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card, a class II device, cleared for Safecare Biotech (Hangzhou) Co., Ltd. on under FDA product code NGG (Test, Methamphetamine, Over The Counter). FDA records list 9 510(k) clearances for Safecare Biotech (Hangzhou) Co., Ltd., from to . As of , FDA records show no recalls naming K182654.

Clearance record

Decision date
Received
(55 days to decision)
Product code
NGG Test, Methamphetamine, Over The Counter
Regulation
21 CFR 862.3610
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Safecare Biotech (Hangzhou) Co., Ltd. Bldg. 2/203 #18 Haishu Rd., Cangqian Sub-District, Hangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NGG

Trailing 12 months

FDA records hold no clearances under product code NGG in the trailing twelve months.

FDA records show no clearances under product code NGG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NGG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260