The following data is part of a premarket notification filed by Access Bio Incorporate with the FDA for Carestart Hcg One-step Pregnancy Test.
| Device ID | K031052 |
| 510k Number | K031052 |
| Device Name: | CARESTART HCG ONE-STEP PREGNANCY TEST |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | ACCESS BIO INCORPORATE 675 US HIGHWAY 1 North Brunswick, NJ 08902 |
| Contact | Young Ho Choi |
| Correspondent | Young Ho Choi ACCESS BIO INCORPORATE 675 US HIGHWAY 1 North Brunswick, NJ 08902 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-02 |
| Decision Date | 2003-06-13 |