CREATINE KINASE MB REAGENT— 510(k) K840783

Substantially Equivalent

American Dade

FDA 510(k) clearance K840783 for CREATINE KINASE MB REAGENT, Substantially Equivalent on 1984-04-04. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1984-02-15
Decision date: 1984-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGS

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 American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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