OLYMPUS TRIGLYCERIDES REAGENTS #SR1021— 510(k) K885266

Name: FDA 510(k) clearance K885266
Creator: U.S. Food and Drug Administration
Published: 1989-02-07

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K885266 for OLYMPUS TRIGLYCERIDES REAGENTS #SR1021, Substantially Equivalent on 1989-02-07. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1988-12-22
Decision date: 1989-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDT

view all

K150819 — Triglycerides2015-08-06
K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT2013-11-22
K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES2013-05-31
K113830 — VANTERA CLINICAL ANALYZER2012-08-30
K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL2011-05-19

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.