SYSTEMATE 2GT - 67207— 510(k) K843268

Name: FDA 510(k) clearance K843268
Creator: U.S. Food and Drug Administration
Published: 1984-09-13

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K843268 for SYSTEMATE 2GT - 67207, Substantially Equivalent on 1984-09-13. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1984-08-20
Decision date: 1984-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JQB

view all

K974000 — Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-301997-11-04
K973157 — LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET1997-10-10
K971466 — SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)1997-05-06
K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES1997-01-13
K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE1997-01-10

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.