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 |
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 |
06937579912370 | K123050 | 000 |
06937579915470 | K123050 | 000 |
06937579915456 | K123050 | 000 |
06937579915401 | K123050 | 000 |
06937579915388 | K123050 | 000 |
06937579915364 | K123050 | 000 |
06937579914190 | K123050 | 000 |
06937579913728 | 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 |
00808829120028 | K123050 | 000 |
06937579913902 | K123050 | 000 |
06937579913926 | K123050 | 000 |
06937579915340 | K123050 | 000 |