TOTAL BILIRUBIN REAGENT - DMSO METHOD— 510(k) K870364

Name: FDA 510(k) clearance K870364
Creator: U.S. Food and Drug Administration
Published: 1987-08-19

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K870364 for TOTAL BILIRUBIN REAGENT - DMSO METHOD, Substantially Equivalent on 1987-08-19. Applicant: Trace Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1987-01-28
Decision date: 1987-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIG

view all

K251998 — Atellica CH Diazo Total Bilirubin (D_TBil)2026-02-27
K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil)2023-06-12
K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil)2023-03-20
K223324 — Total Bilirubin22022-12-29
K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides2019-04-26

More clearances from Trace Scientific , Ltd.

view all

K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT1998-09-17
K981123 — UREA1998-04-24
K962890 — CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)1996-09-27
K961114 — AST INCORPORATING DST1996-05-23
K961123 — ALT INCORPORATING DST1996-04-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.