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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 NameABBOTT COMMANDER(R) PPC AFP-EIA
Classification Namekit, test,alpha-fetoprotein for testicular cancer
Generic Nameafp-eia diagnostic kit
Regulation Number866.6010
ApplicantABBOTT LABORATORIES
PMA NumberP820060
Supplement NumberS005
Date Received05/15/1990
Decision Date08/21/1990
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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