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FDA 510(k), K141827, EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
FDA 510(k), K141827, EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
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510(K) Number: K141827
Device Name: EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
Manufacturer: EUROIMMUN U.S., Inc.
Device Classification Name: antinuclear antibody, indirect immunofluorescent, antigen, control
Regulation Number: 866.5100
Classification Product Code: DHN
Date Received: 07/07/2014
Decision Date: 04/17/2015
Regulation Medical Specialty: Immunology
Device Name: EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
Manufacturer: EUROIMMUN U.S., Inc.
Device Classification Name: antinuclear antibody, indirect immunofluorescent, antigen, control
Regulation Number: 866.5100
Classification Product Code: DHN
Date Received: 07/07/2014
Decision Date: 04/17/2015
Regulation Medical Specialty: Immunology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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