ULTRACLONE 01-700 CELL LINE

Cells, Animal And Human, Cultured

EARL-CLAY LABORATORIES, INC.

The following data is part of a premarket notification filed by Earl-clay Laboratories, Inc. with the FDA for Ultraclone 01-700 Cell Line.

Pre-market Notification Details

Device IDK861569
510k NumberK861569
Device Name:ULTRACLONE 01-700 CELL LINE
ClassificationCells, Animal And Human, Cultured
Applicant EARL-CLAY LABORATORIES, INC. 890 LAMONT AVE. Novato,  CA  94947
ContactSteven A Evans
CorrespondentSteven A Evans
EARL-CLAY LABORATORIES, INC. 890 LAMONT AVE. Novato,  CA  94947
Product CodeKIR  
CFR Regulation Number864.2280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-28
Decision Date1986-05-05

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