TRIGLYCERIDE REAGENT SET— 510(k) K770993

Substantially Equivalent

Macomb Chemical Co.

FDA 510(k) clearance K770993 for TRIGLYCERIDE REAGENT SET, Substantially Equivalent on 1977-09-02. Applicant: Macomb Chemical Co.. Device class: 1.

Clearance details

Applicant: Macomb Chemical Co.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1977-06-01
Decision date: 1977-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDT

K150819 — Triglycerides2015-08-06
K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT2013-11-22
K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES2013-05-31
K113830 — VANTERA CLINICAL ANALYZER2012-08-30
K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL2011-05-19

More clearances from Macomb Chemical Co.

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.