Cleared Traditional

K843732 - API UNISCEPT MIC (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

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

K843732 is an FDA 510(k) clearance for the API UNISCEPT MIC. Classified as Paraquat Assay (product code LTD), Class III - Premarket Approval.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Analytical Products, Inc. devices

Submission Details

510(k) Number K843732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1984
Decision Date October 24, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LTD Paraquat Assay
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.