Cleared Traditional

K843612 - MODIFICATION OF ABL MIC-10 PRECEPT SYS
(FDA 510(k) Clearance)

K843612 · Austin Biological Laboratories · Microbiology
Feb 1985
Decision
159d
Days
Class 3
Risk

K843612 is an FDA 510(k) clearance for the MODIFICATION OF ABL MIC-10 PRECEPT SYS. This device is classified as a Paraquat Assay (Class III — Premarket Approval, product code LTD).

Submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on February 19, 1985, 159 days after receiving the submission on September 13, 1984.

This device falls under the Microbiology FDA review panel.

Submission Details

510(k) Number K843612 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1984
Decision Date February 19, 1985
Days to Decision 159 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LTD — Paraquat Assay
Device Class Class III — Premarket Approval