The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem E Gcg Visual End Point Innumoenz.
| Device ID | K830138 |
| 510k Number | K830138 |
| Device Name: | TANDEM E GCG VISUAL END POINT INNUMOENZ |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | HYBRITECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-13 |
| Decision Date | 1983-02-07 |