Cleared Traditional

API UNISCEPT MIC

K843732 · Analytical Products, Inc. · Microbiology
Oct 1984
Decision
30d
Days
Class 3
Risk

About This 510(k) Submission

K843732 is an FDA 510(k) clearance for the API UNISCEPT MIC, a Paraquat Assay (Class III — Premarket Approval, product code LTD), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on October 24, 1984, 30 days after receiving the submission on September 24, 1984. This device falls under the Microbiology review panel.

Submission Details

510(k) Number K843732 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1984
Decision Date October 24, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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