Cleared Traditional

K790957 - HISTO-DISPENSER

K790957 is the FDA 510(k) clearance for HISTO-DISPENSER by Dynatech Laboratories, Inc.. It is a Class 1 Microbiology device (product code JTC) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K790957 · Dynatech Laboratories, Inc. · Microbiology device
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Jun 1979
Decision
24d
Days
Class 1
Risk

K790957 is an FDA 510(k) clearance for the HISTO-DISPENSER. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Dynatech Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 24 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 Dynatech Laboratories, Inc. devices

Submission Details

510(k) Number K790957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1979
Decision Date June 15, 1979
Days to Decision 24 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
78d faster than avg
Panel avg: 102d · This submission: 24d
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 K790957.
MIC-2000 QUAD INOCULUM TRAY
K790971 · Dynatech Laboratories, Inc. · Jun 1979
MIC-2000 INOCULATOR TEMPLATE
K790974 · Dynatech Laboratories, Inc. · Jun 1979
HISTO-OILER
K790956 · Dynatech Laboratories, Inc. · Jun 1979
INOCULATOR, MIC-2000 DISPOSABLE
K790076 · Dynatech Laboratories, Inc. · Feb 1979
MINIWASH
K781942 · Dynatech Laboratories, Inc. · Dec 1978
MODEL 203 DISPENSER
K761149 · Beckman Instruments, Inc. · Dec 1976