The following data is part of a premarket notification filed by Nantong Biotechnology Co., Ltd. with the FDA for Egens One Step Hcg Urine Pregnancy Test Kit(s) (strip, Cassette, Midstream I And Midstream Ii).
| Device ID | K123050 |
| 510k Number | K123050 |
| Device Name: | EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | NANTONG BIOTECHNOLOGY CO., LTD. 12828 DOE LANE Gaithersburg, MD 20878 |
| Contact | Joe Xia |
| Correspondent | Joe Xia NANTONG BIOTECHNOLOGY CO., LTD. 12828 DOE LANE Gaithersburg, MD 20878 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2013-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00808829111903 | K123050 | 000 |
| 06937579913926 | K123050 | 000 |
| 06937579913728 | K123050 | 000 |
| 06937579914190 | K123050 | 000 |
| 06937579914176 | K123050 | 000 |
| 06937579914152 | K123050 | 000 |
| 06937579914138 | K123050 | 000 |
| 06937579914114 | K123050 | 000 |
| 06937579914091 | K123050 | 000 |
| 00011822887038 | K123050 | 000 |
| 00011822887021 | K123050 | 000 |
| 00011822887069 | K123050 | 000 |
| 00011822887045 | K123050 | 000 |
| 00011822887007 | K123050 | 000 |
| 00048155920200 | K123050 | 000 |
| 06937579913902 | K123050 | 000 |
| 00808829120028 | K123050 | 000 |
| 06937579912134 | K123050 | 000 |
| 06937579911618 | K123050 | 000 |
| 06937579911601 | K123050 | 000 |
| 06937579911281 | K123050 | 000 |
| 06937579911274 | K123050 | 000 |
| 06937579911267 | K123050 | 000 |
| 06937579911250 | K123050 | 000 |
| 06937579911243 | K123050 | 000 |
| 06937579911236 | K123050 | 000 |
| 05055718942376 | K123050 | 000 |
| 05055718942345 | K123050 | 000 |
| 05055718942314 | K123050 | 000 |
| 05055718942307 | K123050 | 000 |
| 05055718942284 | K123050 | 000 |
| 06937579912370 | K123050 | 000 |