FLOW-PAC CPK REAGENT SET— 510(k) K832977

Name: FDA 510(k) clearance K832977
Creator: U.S. Food and Drug Administration
Published: 1984-04-05

Substantially Equivalent

American Research Products Co.

FDA 510(k) clearance K832977 for FLOW-PAC CPK REAGENT SET, Substantially Equivalent on 1984-04-05. Applicant: American Research Products Co.. Device class: 2.

Clearance details

Applicant: American Research Products Co.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1983-09-02
Decision date: 1984-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHY

view all

K143720 — Dimension Vista MMB Assay2015-09-18
K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL2014-05-13
K140404 — ELECSYS CK-MB STAT IMMUNOASSAY2014-05-08
K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY2013-10-18
K070835 — OLYMPUS CK-MB REAGENT2007-06-04

More clearances from American Research Products Co.

view all

K942984 — BUN REAGENT1995-03-01
K901527 — BIURET (COLORMETRIC), TOTAL PROTEIN1990-07-19
K901960 — IRON REAGENTS PRODUCT CODES 7725 AND 77261990-05-31
K901964 — PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/74631990-05-31
K900827 — COLORIMETRIC CHLORIDE PRODUCT #43141251990-05-02

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