25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441

K930378 · Proteins Intl., Inc. · KIR · Mar 23, 1993 · Hematology

Device Facts

Record IDK930378
Device Name25 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-441
ApplicantProteins Intl., Inc.
Product CodeKIR · Hematology
Decision DateMar 23, 1993
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 864.2280
Device ClassClass 1

Regulatory Classification

Identification

Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

Innolitics

Panel 1

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