Cleared Traditional

K831341 - API UNISCEPT PLUS AUTOINOCULATOR

K831341 is an FDA 510(k) clearance for API UNISCEPT PLUS AUTOINOCULATOR, manufactured by Analytical Products, Inc.. The device is a Class 1 Immunology device with product code JTC cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K831341 · Analytical Products, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
38d
Days
Class 1
Risk

K831341 is an FDA 510(k) clearance for the API UNISCEPT PLUS AUTOINOCULATOR. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2500 - the FDA immunology 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 Analytical Products, Inc. devices

FDA 510(k) Submission Details - K831341

510(k) Number K831341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date June 02, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 105d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

JTC Device Classification - Class 1, General Controls

Product Code JTC Device, Microtiter Diluting/dispensing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2500
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 - JTC Device, Microtiter Diluting/dispensing

All 36
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K831341.
API UNISCEPT PLUS 140 INOCULATOR
K831462 · Analytical Products, Inc. · Aug 1983
WASHER 6000 MICRO-C LISA SYSTEM
K831640 · Organon Teknika Corp. · Aug 1983
PIPETTE 12 CHANNEL
K831644 · Organon Teknika Corp. · Aug 1983
MUELLER HINTON W/50% SHEEP BLOOD
K830059 · bioMerieux, Inc. · Feb 1983
DISPOSABLE DISPENSE MANIFOLD
K823218 · Dynatech Laboratories, Inc. · Nov 1982
MIC-2000 PLUS, 96 CHANNEL DISPENSER
K820821 · Dynatech Corp. · Apr 1982