The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for A-just Turbidity Meter.
Device ID | K851234 |
510k Number | K851234 |
Device Name: | A-JUST TURBIDITY METER |
Classification | Nephelometer, For Clinical Use |
Applicant | ABBOTT LABORATORIES 1921 HURD DR. P.O.BOX 152020 Irving, TX 75015 -2020 |
Contact | Beverly G Chamber |
Correspondent | Beverly G Chamber ABBOTT LABORATORIES 1921 HURD DR. P.O.BOX 152020 Irving, TX 75015 -2020 |
Product Code | JQX |
CFR Regulation Number | 862.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-26 |
Decision Date | 1985-04-29 |