FRESHFROZEN CELLS, HEP-2

Cells, Animal And Human, Cultured

DIAGNOSTIC HYBRIDS, INC.

The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Freshfrozen Cells, Hep-2.

Pre-market Notification Details

Device IDK962782
510k NumberK962782
Device Name:FRESHFROZEN CELLS, HEP-2
ClassificationCells, Animal And Human, Cultured
Applicant DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. Athens,  OH  45701
ContactJames L Brown
CorrespondentJames L Brown
DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. Athens,  OH  45701
Product CodeKIR  
CFR Regulation Number864.2280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-17
Decision Date1996-08-29
Summary:summary

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