The following data is part of a premarket notification filed by Co-innovation Biotech Co., Ltd. with the FDA for One Step Hcg Test Strip, One Step Hcg Test Cassette, One Step Hcg Test Midstream.
| Device ID | K132085 |
| 510k Number | K132085 |
| Device Name: | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | CO-INNOVATION BIOTECH CO., LTD. NO. 13 YANYUAN ROAD. TIANHE DISTRICT Guangzhou, Guangdong, CN 510507 |
| Contact | Hong Feng |
| Correspondent | Hong Feng CO-INNOVATION BIOTECH CO., LTD. NO. 13 YANYUAN ROAD. TIANHE DISTRICT Guangzhou, Guangdong, CN 510507 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-05 |
| Decision Date | 2013-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20852359007049 | K132085 | 000 |
| 06974464590084 | K132085 | 000 |