FDA.reportPublic FDA data

510(k) K010877

Device
CHEMWELL, MODEL 2900
Applicant
Awareness Technology, Inc.
510(k) number
K010877
Product code
CIX
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-23
Date received
2001-03-23
Regulation
862.1035
Classification name
Bromcresol Green Dye-Binding, Albumin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Abbreviated
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARY FREEMAN
Address
1995 SW Martin Hwy. P.O. Box 1679 Palm City FL US 34990 34990

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K060434ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICALHoriba Abx2007-06-05
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