HEMOGLOBIN ANALYZER & PERFORM. CHECK SET— 510(k) K771101

Name: FDA 510(k) clearance K771101
Creator: U.S. Food and Drug Administration
Published: 1977-07-21

Substantially Equivalent

The Dow Chemical Co.

FDA 510(k) clearance K771101 for HEMOGLOBIN ANALYZER & PERFORM. CHECK SET, Substantially Equivalent on 1977-07-21. Applicant: The Dow Chemical Co.. Device class: 2.

Clearance details

Applicant: The Dow Chemical Co.
Product code: Code GIG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1977-06-20
Decision date: 1977-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GIG

view all

K973995 — RANDOX BILIRUBIN1997-12-08
K933836 — HBM HEMOGLOBINOMETER1994-03-31

More clearances from The Dow Chemical Co.

view all

K823474 — ENZYMATIC GLUCOSE DETERMINATION1982-12-30
K822154 — UREA NITROGEN (ENZYMATIC) DETERMINATION1982-08-05
K821536 — DOWFLOW ALT-UV DETERMINATION1982-06-14
K821315 — DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM1982-05-24
K820675 — BILIRUBIN(TOTAL) DETERMINATION CTMS1982-04-01

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