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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameARCHITECT ANTI-HCV ASSAY/CALIBRATOR/CONTROL
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantABBOTT LABORATORIES INC
PMA NumberP050042
Supplement NumberS005
Date Received01/28/2009
Decision Date06/23/2009
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend the application of the architect anti-hcv assay, currently approved for use on the abbott architect i2000/ i 2000sr, onto a new architect i system family member, the architect i 1000sr.
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