DIRECT BILIRUBIN— 510(k) K860257

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K860257 for DIRECT BILIRUBIN, Substantially Equivalent on 1986-02-21. Applicant: Pointe Scientific, Inc.,.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1986-01-24
Decision date: 1986-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

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