Cleared Traditional

K831642 - HEATING BLOCK MICROELISA SYSTEM

K831642 is an FDA 510(k) clearance for HEATING BLOCK MICROELISA SYSTEM, manufactured by Organon Teknika Corp.. The device is a Class 1 Chemistry device with product code LIB cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K831642 · Organon Teknika Corp. · Chemistry device
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Jul 1983
Decision
64d
Days
Class 1
Risk

K831642 is an FDA 510(k) clearance for the HEATING BLOCK MICROELISA SYSTEM. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Organon Teknika Corp. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - the FDA in vitro diagnostics and chemistry 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K831642

510(k) Number K831642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date July 26, 1983
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

LIB Device Classification - Class 1, General Controls

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - LIB Device, General Purpose, Microbiology, Diagnostic

All 26
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K831642.
GIARDIA GUARD
K842052 · Gelman Sciences, Inc. · Sep 1984
READER MICROELISA SYSTEM
K831641 · Organon Teknika Corp. · Aug 1983
IMMULON SUBSTRATE REMOVAWELL STRIPS
K832117 · Dynatech Corp. · Aug 1983
STRIPREADER MICROELISA SYSTEM
K831643 · Organon Teknika Corp. · Jul 1983
MICROELISA COMP
K831658 · Organon Teknika Corp. · Jul 1983
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS
K831448 · R&D Systems, Inc. · Jun 1983