Cleared Traditional

K962311 - FRESHFROZENCELLS

K962311 is an FDA 510(k) clearance for FRESHFROZENCELLS, manufactured by Diagnostic Hybrids, Inc.. The device is a Class 1 Microbiology device with product code KIR cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K962311 · Diagnostic Hybrids, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
73d
Days
Class 1
Risk

K962311 is an FDA 510(k) clearance for the FRESHFROZENCELLS. 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 August 29, 1996 after a review of 73 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

FDA 510(k) Submission Details - K962311

510(k) Number K962311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1996
Decision Date August 29, 1996
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

KIR Device Classification - Class 1, General Controls

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 154
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K962311.
FRESHCELLS
K972414 · Diagnostic Hybrids, Inc. · Aug 1997
MINK LUNG CELL CULTURE
K965047 · Neogenex · Feb 1997
FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES
K962306 · Diagnostic Hybrids, Inc. · Aug 1996
FRESHCELLS, HEP-2
K962780 · Diagnostic Hybrids, Inc. · Aug 1996
FRESHFROZEN CELLS, HEP-2
K962782 · Diagnostic Hybrids, Inc. · Aug 1996
MCCOY CELL CULTURES
K955608 · Vai Diagnostics, Inc. · Jul 1996