The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo One Step Fecal Occult Blood (fob) Test.
| Device ID | K162333 |
| 510k Number | K162333 |
| Device Name: | Wondfo One Step Fecal Occult Blood (FOB) Test |
| Classification | Reagent, Occult Blood |
| Applicant | GUANGZHOU WONDFO BIOTECH CO., LTD. WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY Guangzhou, CN 510641 |
| Contact | Bin Chen |
| Correspondent | Joe Shia LSI INTERNATIONAL INC. 504 E DIAMOND AVE., SUITE I Gaithersburg, MD 20877 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-22 |
| Decision Date | 2017-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816862021575 | K162333 | 000 |
| 10816862021568 | K162333 | 000 |
| 10816862021148 | K162333 | 000 |
| 10816862021131 | K162333 | 000 |
| 10816862021124 | K162333 | 000 |