BIO-RAD CYCLOSPORINE BY HPLC TEST

High Performance Liquid Chromatography For Cyclosporine

FDA Premarket Approval P880032

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceBIO-RAD CYCLOSPORINE BY HPLC TEST
Classification NameHigh Performance Liquid Chromatography For Cyclosporine
Generic NameHigh Performance Liquid Chromatography For Cyclosporine
ApplicantBio-Rad
Date Received1988-04-21
Decision Date1989-07-24
Notice Date1989-08-22
PMAP880032
SupplementS
Product CodeMGS
Docket Number89M-0321
Advisory CommitteeClinical Chemistry
Expedited ReviewNo
Combination Product No
Applicant Address Bio-Rad 4000 Alfred Nobel Dr. hercules, CA 94547-1803

Supplemental Filings

Supplement NumberDateSupplement Type
P880032Original Filing
S002 1993-03-16 Normal 180 Day Track
S001 1990-12-06 Normal 180 Day Track

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