The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for Ez-hcg Urine(pregnancy Test).
| Device ID | K003856 |
| 510k Number | K003856 |
| Device Name: | EZ-HCG URINE(PREGNANCY TEST) |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Jay Singh |
| Correspondent | Jay Singh BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-13 |
| Decision Date | 2001-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00083059104851 | K003856 | 000 |
| 08305901048253 | K003856 | 000 |