Cleared Traditional

K812818 - TITERTEK AUTODROP

K812818 is the FDA 510(k) clearance for TITERTEK AUTODROP by Flow Laboratories, Inc.. It is a Class 1 Microbiology device (product code JTC) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K812818 · Flow Laboratories, Inc. · Microbiology device
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Oct 1981
Decision
16d
Days
Class 1
Risk

K812818 is an FDA 510(k) clearance for the TITERTEK AUTODROP. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1981 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2500 - 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 Flow Laboratories, Inc. devices

Submission Details

510(k) Number K812818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1981
Decision Date October 23, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 29
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K812818.
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HIPPURATE DISK
K801305 · Remel Co. · Jul 1980