Cleared Traditional

K850908 - TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA

K850908 is an FDA 510(k) clearance for TITERTEK MICROITTRATION EQUIP. HANDIWAS..., manufactured by Flow Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTC cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K850908 · Flow Laboratories, Inc. · Microbiology device
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Mar 1985
Decision
20d
Days
Class 1
Risk

K850908 is an FDA 510(k) clearance for the TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mclean, US). The FDA issued a Cleared decision on March 25, 1985 after a review of 20 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.

FDA 510(k) Submission Details - K850908

510(k) Number K850908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date March 25, 1985
Days to Decision 20 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
82d faster than avg
Panel avg: 102d · This submission: 20d
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 65
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K850908.
SPR 2 AUTODILUTER
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MIC-CONCEPT INOCULUM SEED TRAY
K851019 · Microtech Medical Systems, Inc. · Mar 1985
MIC-CONCEPT INOCULATOR
K851020 · Microtech Medical Systems, Inc. · Mar 1985
BIO-TEK AUTOMATED MICROPLATE WASHER EL402
K850249 · Bio-Tek Instruments, Inc. · Mar 1985
INTIWASH MANUAL MICROPLATE WASHER
K850371 · Inti Corp. · Mar 1985
SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES
K844891 · Slt Labinstruments, Inc. · Feb 1985
K850908 · TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA
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