The following data is part of a premarket notification filed by Healgen Scientific, Llc with the FDA for Healgen Hcg One Step Pregnancy Test (strip), Healgen Hcg One Step Pregnancy Test (cassette).
| Device ID | K123703 |
| 510k Number | K123703 |
| Device Name: | HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | HEALGEN SCIENTIFIC, LLC 3818 FUQUA STREET Houston, TX 77401 |
| Contact | Bryan Fang |
| Correspondent | Bryan Fang HEALGEN SCIENTIFIC, LLC 3818 FUQUA STREET Houston, TX 77401 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-03 |
| Decision Date | 2013-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810038632527 | K123703 | 000 |
| 10810038633692 | K123703 | 000 |
| 10810038633593 | K123703 | 000 |