Cleared Traditional

BILIRUBIN TOTAL DIRECT

K863057 · J. D. Assoc. · Chemistry
Sep 1986
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K863057 is an FDA 510(k) clearance for the BILIRUBIN TOTAL DIRECT, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 26, 1986, 45 days after receiving the submission on August 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K863057 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1986
Decision Date September 26, 1986
Days to Decision 45 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

Similar Devices — CIG Diazo Colorimetry, Bilirubin

All 234
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · Siemens Healthcare Diagnostics, Inc. · Feb 2026
Atellica? CH Diazo Direct Bilirubin (D_DBil)
K223078 · Siemens Healthcare Diagnostics, Inc. · Jun 2023
Atellica? CH Diazo Total Bilirubin (D_TBil)
K222104 · Siemens Healthcare Diagnostics, Inc. · Mar 2023
Total Bilirubin2
K223324 · Abbott Ireland Diagnostics Division · Dec 2022
VITROS XT Chemistry Products TBIL-ALKP Slides
K190807 · Ortho-Clinical Diagnostics, Inc. · Apr 2019
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
K171401 · Elitechgroup · Jul 2017