CREATINE KINASE REAGENT SYSTEM— 510(k) K952745

Name: FDA 510(k) clearance K952745
Creator: U.S. Food and Drug Administration
Published: 1995-08-11

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K952745 for CREATINE KINASE REAGENT SYSTEM, Substantially Equivalent on 1995-08-11. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1995-06-16
Decision date: 1995-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGS

view all

K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set2020-08-11
K182702 — SEKURE Creatine Kinase Assay2019-04-17
K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator2016-09-07
K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR2013-11-21
K112416 — CPK REAGENT2011-11-09

More clearances from Medical Diagnostic Technologies, Inc.

view all

K062229 — CTC WORKSTATION, MODEL 22002006-09-11
K972209 — SPECTROLYSE HEPARIN (ANTI-IIA)1997-08-12
K963106 — CHROMOLIZE PAI-1 KIT1996-11-18
K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA)1996-08-14
K962489 — CHROMOLIZE TPA ASSAY KIT1996-07-31

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