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

Dna Specimen Collection, Saliva

21 CFR 862.1675 / Clinical Chemistry
FDA source (opens on fda.gov)

OYJ is the FDA product code for Dna Specimen Collection, Saliva, a class II device type, regulated under 21 CFR 862.1675. FDA's definition for this code reads: "A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OYJ
Device name
Dna Specimen Collection, Saliva
FDA definition
A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code OYJ

By decision year
7 clearances under product code OYJ with a decision year between 2011 and 2022, 2016 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OYJ by decision year
YearClearances
20111
20151
20162
20202
20221

Applicants with the most clearances

Product code OYJ
Applicants holding the most 510(k) clearances under product code OYJ
ApplicantClearances
DNA Genotek Inc.6
Ancestry Genomics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order