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ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN160025
510(k) Type
Direct
Applicant
ID-FISH TECHNOLOGY, INC
Country
United States
FDA Decision
Deleted
Decision Date
8/18/2017
Days to Decision
417 days

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN160025
510(k) Type
Direct
Applicant
ID-FISH TECHNOLOGY, INC
Country
United States
FDA Decision
Deleted
Decision Date
8/18/2017
Days to Decision
417 days