TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS— 510(k) K892668

Name: FDA 510(k) clearance K892668
Creator: U.S. Food and Drug Administration
Published: 1989-07-20

Substantially Equivalent

Catachem, Inc.

FDA 510(k) clearance K892668 for TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS, Substantially Equivalent on 1989-07-20. Applicant: Catachem, Inc.. Device class: 2.

Clearance details

Applicant: Catachem, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1989-04-13
Decision date: 1989-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Chester, NY, US

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 Catachem, Inc.

view all

K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT2007-01-19
K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER1995-02-22
K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER1993-09-08
K903341 — MAGNESIUM1990-08-22
K902326 — AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS1990-07-31

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