SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA— 510(k) K801926

Name: FDA 510(k) clearance K801926
Creator: U.S. Food and Drug Administration
Published: 1980-09-09

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K801926 for SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA, Substantially Equivalent on 1980-09-09. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1980-08-12
Decision date: 1980-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KQJ

view all

K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL2025-07-24
K073367 — HEMOSIL FIBRINOGEN-C2007-12-27
K050928 — DADE THROMBIN REAGENT2005-06-29
K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)1997-10-09
K970189 — FIF TM1997-05-21

More clearances from Sigma Chemical Co.

view all

K933694 — SIGMA GLUCOSE REAGENT1994-11-04
K933678 — SIGMA CALCIUM REAGENT1994-03-11
K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT1994-01-03
K933679 — SIGMA BUN REAGENT1993-12-17
K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT1993-12-17

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