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

Data Acquisition Software

21 CFR 862.2570 / Clinical Chemistry
FDA source (opens on fda.gov)

PQQ is the FDA product code for Data Acquisition Software, a class II device type, regulated under 21 CFR 862.2570. FDA's definition for this code reads: "Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
PQQ
Device name
Data Acquisition Software
FDA definition
Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments.
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
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