Cleared Traditional

K851234 - A-JUST TURBIDITY METER
(FDA 510(k) Clearance)

Apr 1985
Decision
34d
Days
Class 1
Risk

K851234 is an FDA 510(k) clearance for the A-JUST TURBIDITY METER. This device is classified as a Nephelometer, For Clinical Use (Class I - General Controls, product code JQX).

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on April 29, 1985, 34 days after receiving the submission on March 26, 1985.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.2700.

Submission Details

510(k) Number K851234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date April 29, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JQX — Nephelometer, For Clinical Use
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2700