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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.
Classification Namehigh performance liquid chromatography for cyclosporine
Generic Namehigh performance liquid chromatography
Regulation Number862.1235
PMA NumberP880032
Supplement NumberS002
Date Received03/16/1993
Decision Date03/01/1996
Product Code
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in manufacturer site of the analytical cartridge from the life science group of bio-rad laboratories located in richmond, ca to the clinical systems division of the diagnostics group of bio-rad laboratories located in hercules, ca. , and changing the vendor of the "clean up" columns for the cyclosporin test by hplc.