The following data is part of a premarket notification filed by Bio Focus Co., Lt. with the FDA for Pure-aid Pregnancy Test.
| Device ID | K053452 |
| 510k Number | K053452 |
| Device Name: | PURE-AID PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BIO FOCUS CO., LT. 251E. REDONDO BEACH BLVD. Gardena, CA 90248 |
| Contact | Lauren Hong |
| Correspondent | Lauren Hong BIO FOCUS CO., LT. 251E. REDONDO BEACH BLVD. Gardena, CA 90248 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-12 |
| Decision Date | 2006-05-25 |