ENZYMATIC REAGENT SET, 4X250 ML.— 510(k) K791511

Name: FDA 510(k) clearance K791511
Creator: U.S. Food and Drug Administration
Published: 1979-09-04

Substantially Equivalent

Macomb Chemical Co.

FDA 510(k) clearance K791511 for ENZYMATIC REAGENT SET, 4X250 ML., Substantially Equivalent on 1979-09-04. Applicant: Macomb Chemical Co.. Device class: 1.

Clearance details

Applicant: Macomb Chemical Co.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1979-07-26
Decision date: 1979-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHH

view all

K251091 — Lipids2025-12-30
K232404 — CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES2024-08-09
K203597 — Cholesterol22022-06-30
K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides2019-03-27
K181373 — Extended Lipid Panel Assay2018-10-18

More clearances from Macomb Chemical Co.

view all

K830095 — RAPID CHEM ANALYZER II1983-01-28
K823720 — SPECTROPHOTOMETER1983-01-07
K810958 — GLYCOHEMOGLOBIN1981-09-16
K801086 — P-NITROPHENYL PHOSPHATE1980-05-28
K800719 — ENZYMATIC UREA NITROGEN REAGENT SET REVI1980-05-08

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