The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Testpack Plus Hcg Urine.
| Device ID | K954029 |
| 510k Number | K954029 |
| Device Name: | TESTPACK PLUS HCG URINE |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Contact | Joy C Sonsalla |
| Correspondent | Joy C Sonsalla ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-28 |
| Decision Date | 1995-10-05 |