HEMA SCREEN SPECIFIC IFOBT— 510(k) K060463

Substantially Equivalent

Immunostics Inc.,

FDA 510(k) clearance K060463 for HEMA SCREEN SPECIFIC IFOBT, Substantially Equivalent on 2006-06-06. Applicant: Immunostics Inc.,.

Clearance details

Applicant
Immunostics Inc.,
Product code
Code KHE
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ocean, NJ, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.