The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Pharamacokinetics Systems.
Device ID | K851573 |
510k Number | K851573 |
Device Name: | ABBOTT PHARAMACOKINETICS SYSTEMS |
Classification | Medical Computers And Software |
Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Contact | Mary E Zorc |
Correspondent | Mary E Zorc ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Product Code | LNX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-17 |
Decision Date | 1986-01-08 |