UNISCEPT(TM)

FDA Premarket Approval P830028

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

DeviceUNISCEPT(TM)
Generic NameManual Antimicrobial Susceptibility Test Systems
ApplicantANALYTICAL PRODUCTS, INC.
Date Received1983-03-25
Decision Date1984-03-01
Notice Date1984-04-25
PMAP830028
SupplementS
Product CodeJWY 
Docket Number84M-0129
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address ANALYTICAL PRODUCTS, INC. 200 Express Street plainview , NY 11803-

Supplemental Filings

Supplement NumberDateSupplement Type
P830028Original Filing
S001 1984-01-25

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