Cleared Traditional

K973214 - FRESH CELLS HFF

K973214 is the FDA 510(k) clearance for FRESH CELLS HFF by Diagnostic Hybrids, Inc.. It is a Class 1 Microbiology device (product code KIR) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K973214 · Diagnostic Hybrids, Inc. · Microbiology device
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Sep 1997
Decision
29d
Days
Class 1
Risk

K973214 is an FDA 510(k) clearance for the FRESH CELLS HFF. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2280 - 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 Diagnostic Hybrids, Inc. devices

Submission Details

510(k) Number K973214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1997
Decision Date September 25, 1997
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
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 - KIR Cells, Animal And Human, Cultured

All 79
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K973214.
FRESH CELLS MV1LU
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K973212 · Diagnostic Hybrids, Inc. · Sep 1997
FRESH CELLS LLC-MK2
K973213 · Diagnostic Hybrids, Inc. · Sep 1997
FRESHCELLS
K972414 · Diagnostic Hybrids, Inc. · Aug 1997
FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES
K962306 · Diagnostic Hybrids, Inc. · Aug 1996
FRESHFROZENCELLS
K962311 · Diagnostic Hybrids, Inc. · Aug 1996