The following data is part of a premarket notification filed by Innovacon, Inc. with the FDA for Innovacon Hcg Uktra Test Device.
| Device ID | K062361 |
| 510k Number | K062361 |
| Device Name: | INNOVACON HCG UKTRA TEST DEVICE |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | INNOVACON, INC. 4106 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung INNOVACON, INC. 4106 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-14 |
| Decision Date | 2006-10-23 |
| Summary: | summary |