The following data is part of a premarket notification filed by Runbio Biotech Co., Ltd. with the FDA for David Pregnancy Test (midstream).
| Device ID | K053236 |
| 510k Number | K053236 |
| Device Name: | DAVID PREGNANCY TEST (MIDSTREAM) |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | RUNBIO BIOTECH CO., LTD. 2941 61ST. AVE NE Tacoma, WA 98422 |
| Contact | Jessica Vagata |
| Correspondent | Jessica Vagata RUNBIO BIOTECH CO., LTD. 2941 61ST. AVE NE Tacoma, WA 98422 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-18 |
| Decision Date | 2006-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938444980012 | K053236 | 000 |
| 06938444985017 | K053236 | 000 |