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510(k) Data Aggregation
K Number
K062932Device Name
AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
Manufacturer
AHLSTROM MOUNT HOLLY SPRINGS LLC
Date Cleared
2007-10-19
(386 days)
Product Code
JKA, PJC
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
AHLSTROM MOUNT HOLLY SPRINGS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ahlstrom 226 specimen collection paper is intended to be used as a medium to collect and transport blood specimen spots to a laboratory. The 226 paper will be in the format of a printed card that may be incorporated along with a tear-apart form for demographic information.
Device Description
Ahlstrom 226 specimen collection paper is designed to provide a uniform surface for the collection of blood spots. A drop of blood is applied to the filter paper and allowed to soak through the paper. The sample is then air dried and sent to a laboratory for further analysis.
This specimen collection paper is made from 100 % pure cotton linters with no wetstrength additives added and conforms to the Recognized Consensus Standard NCCLS LA4-A3.
This device has 4 crucial performance characteristics that can be performed with lysed or intact red blood cells: blood absorption time, blood spot diameter, serum absorption volume, and homogeneity.
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