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ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) — Biokit, S.A. (510(k) K060027)

ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) — Biokit, S.A. (510(k) K060027) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH); Applicant: Biokit, S.A.; Clearance track: 510(k).

Device nameARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
ApplicantBiokit, S.A.
Clearance track510(k)
Submission numberK060027
DecisionSubstantially Equivalent
Decision date2006-01-26
Date received2006-01-04
Product codeJJX
Device class1
Medical specialtyClinical Chemistry
Applicant locationES
SourceopenFDA device

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