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

Self-Contained Blood Grouping

21 CFR 864.9175 / Hematology
FDA source (opens on fda.gov)

OQX is the FDA product code for Self-Contained Blood Grouping, a class II device type, regulated under 21 CFR 864.9175. FDA's definition for this code reads: "Intended for single use for individual blood group determination for educational and informational purposes". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OQX
Device name
Self-Contained Blood Grouping
FDA definition
Intended for single use for individual blood group determination for educational and informational purposes
Regulation
21 CFR 864.9175
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OQX.