The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Propoxyphene Urine Test.
Device ID | K152495 |
510k Number | K152495 |
Device Name: | Wondfo Propoxyphene Urine Test |
Classification | Enzyme Immunoassay, Propoxyphene |
Applicant | Guangzhou Wondfo Biotech Co., Ltd. Wondfo Scientech Park, South China Univ. Of Technology Guangzhou, CN 510641 |
Contact | Ben Chen |
Correspondent | Joe Shia LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, MD 20877 |
Product Code | JXN |
CFR Regulation Number | 862.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-01 |
Decision Date | 2015-11-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816036025623 | K152495 | 000 |