CREATINE KINASE-MB (CK-MB) REAGENT SET— 510(k) K915709

Name: FDA 510(k) clearance K915709
Creator: U.S. Food and Drug Administration
Published: 1992-01-27

Substantially Equivalent

Tech Intl. Co.

FDA 510(k) clearance K915709 for CREATINE KINASE-MB (CK-MB) REAGENT SET, Substantially Equivalent on 1992-01-27. Applicant: Tech Intl. Co.. Device class: 2.

Clearance details

Applicant: Tech Intl. Co.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1991-11-29
Decision date: 1992-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester Hills, MI, 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 Tech Intl. Co.

view all

K915704 — AMYLASE (KINETIC) REAGENT SET1996-06-28
K915705 — ACID PHOSPHATASE REAGENT SET1992-02-27
K915707 — AMMONIA REAGENT SET1992-02-26
K914158 — URIC ACID REAGENT SET1992-02-21
K915706 — LIPASE REAGENT SET1992-02-18

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