PMA P150041S002

Device

Vysis CLL FISH Probe Kit

Applicant

Abbott Molecular, Inc.

PMA number

P150041

Supplement

S002

Product code

PNK

Decision date

2018-03-12

Classification

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)

Generic name

Fluorescence in situ hybridization, chromosome 17p deletion (TP53)

Approval order statement

Changes to the manufacturing process and manufacturing site of a suppliers product.

Summary

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