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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 NameHYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate_specific antigen (psa) for management o
Regulation Number866.6010
ApplicantHYBRITECH, INC.
PMA NumberP850048
Supplement NumberS009
Date Received06/29/1992
Decision Date08/25/1994
Product Code
LTJ[ Registered Establishments with LTJ ]
Docket Number 94M-0327
Notice Date 10/14/1994
Advisory Committee Immunology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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