510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OYUClass II

Dna-Probe Kit, Human Chromosome

21 CFR 866.4700 / Immunology
FDA source (opens on fda.gov)

OYU is the FDA product code for Dna-Probe Kit, Human Chromosome, a class II device type, regulated under 21 CFR 866.4700. FDA's definition for this code reads: "Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OYU
Device name
Dna-Probe Kit, Human Chromosome
FDA definition
Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen.
Regulation
21 CFR 866.4700
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code OYU

By decision year
3 clearances under product code OYU with a decision year between 1996 and 2001, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OYU by decision year
YearClearances
19961
19971
20011

Applicants with the most clearances

Product code OYU
Applicants holding the most 510(k) clearances under product code OYU
ApplicantClearances
Vysis3

Companies listing this code with FDA

Companies whose registered establishments list this code