MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)— 510(k) K853127

Substantially Equivalent

Micromedic Systems

FDA 510(k) clearance K853127 for MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL), Substantially Equivalent on 1985-09-16. Applicant: Micromedic Systems. Device class: 2.

Clearance details

Applicant
Micromedic Systems
Product code
Product code CDD
Device class
Class 2
Regulation
21 CFR 862.1810
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Horsham, PA, US
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