Cleared Traditional

K964144 - PARACON PLUS FORMALIN - PCP-F

K964144 is the FDA 510(k) clearance for PARACON PLUS FORMALIN - PCP-F by Para Scientific Co.. It is a Class 1 Microbiology device (product code LIO) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K964144 · Para Scientific Co. · Microbiology device
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Nov 1996
Decision
41d
Days
Class 1
Risk

K964144 is an FDA 510(k) clearance for the PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF.... Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Para Scientific Co. (Lake Oswego, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Para Scientific Co. devices

Submission Details

510(k) Number K964144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1996
Decision Date November 27, 1996
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIO Device, Specimen Collection

All 17
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