The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Hcg Detector Combi, Hcg Detector Stix, Hcg Detector Cassette.
| Device ID | K041728 |
| 510k Number | K041728 |
| Device Name: | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-25 |
| Decision Date | 2004-08-11 |