SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406— 510(k) K932159

Name: FDA 510(k) clearance K932159
Creator: U.S. Food and Drug Administration
Published: 1993-09-21

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K932159 for SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406, Substantially Equivalent on 1993-09-21. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1993-05-04
Decision date: 1993-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, 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 Em Diagnostic Systems, Inc.

view all

K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST1994-01-27
K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST1994-01-13
K935178 — EMDS PHOSPHOROUS (PHOS) TEST1993-12-17
K935179 — EMDS ALBUMIN (ALB) TEST1993-12-17
K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 654101993-12-16

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