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

Research Use Only/Microbiology

Unknown
FDA source (opens on fda.gov)

OTT is the FDA product code for Research Use Only/Microbiology. FDA's definition for this code reads: "For research use only and for products imported into the US only". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OTT
Device name
Research Use Only/Microbiology
FDA definition
For research use only and for products imported into the US only.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code