TOTAL BILIRUBIN L.F.— 510(k) K895822

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K895822 for TOTAL BILIRUBIN L.F., Substantially Equivalent on 1989-11-14. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1989-09-29
Decision date: 1989-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

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