Device Classification Name |
test, opiates, over the counter
|
510(k) Number |
K240654 |
Device Name |
SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette |
Applicant |
Safecare Biotech (Hangzhou) Co., Ltd. |
Building 2/203 No.18 Haishu Rd., Cangqian Sub-district |
Yuhang District |
Hangzhou,
CN
311121
|
|
Applicant Contact |
Alex Qiu |
Correspondent |
LSI International Inc |
504E Diamond Ave., Suite H |
Gaithersburg,
MD
20877
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.3650
|
Classification Product Code |
|
Date Received | 03/07/2024 |
Decision Date | 04/10/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|