Cleared Traditional

TOTAL BILIRUBIN L.F.

K895822 · Sclavo, Inc. · Chemistry
Nov 1989
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K895822 is an FDA 510(k) clearance for the TOTAL BILIRUBIN L.F., a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on November 14, 1989, 46 days after receiving the submission on September 29, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K895822 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1989
Decision Date November 14, 1989
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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