DYNAZYME-II TM CK-230 KIT— 510(k) K761344

Name: FDA 510(k) clearance K761344
Creator: U.S. Food and Drug Administration
Published: 1977-01-05

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K761344 for DYNAZYME-II TM CK-230 KIT, Substantially Equivalent on 1977-01-05. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1976-12-28
Decision date: 1977-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 J.T. Baker Chemical Co.

view all

K803128 — SERIES 810 PLATELET ANALYZER1981-04-03
K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT1980-10-10
K801909 — LSA 290 ASSAY REAGENTS/NEPHELOMETRIC1980-09-26
K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT1980-09-26
K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC1980-09-16

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