Cleared Traditional

BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04

K991866 · A.P. Total Care, Inc. · Chemistry
Aug 1999
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K991866 is an FDA 510(k) clearance for the BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on August 2, 1999, 62 days after receiving the submission on June 1, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K991866 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1999
Decision Date August 02, 1999
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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