The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Testpack Plus Hcg Combo With Obc.
| Device ID | K965116 |
| 510k Number | K965116 |
| Device Name: | ABBOTT TESTPACK PLUS HCG COMBO WITH OBC |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ABBOTT LABORATORIES DEPT. 389, AP30 200 ABBOTT PARK RD. Abbott Park, IL 60064 -3537 |
| Contact | Karen L Gates |
| Correspondent | Karen L Gates ABBOTT LABORATORIES DEPT. 389, AP30 200 ABBOTT PARK RD. Abbott Park, IL 60064 -3537 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-20 |
| Decision Date | 1997-02-20 |
| Summary: | summary |