FDA-Device2022-04-20Class II
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Stanbio Laboratory, LP
Hazard
The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
Sold states
US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
Affected count
50
Manufactured in
1261 N Main St, N/A, Boerne, TX, United States
Products
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0905-2022Don't want to check this manually?
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