NITRO BLUE TETRAZOLIUM REDUCTION— 510(k) K904022

Name: FDA 510(k) clearance K904022
Creator: U.S. Food and Drug Administration
Published: 1990-12-18

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K904022 for NITRO BLUE TETRAZOLIUM REDUCTION, Substantially Equivalent on 1990-12-18. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code GHD
Device class: Class 1
Regulation: 21 CFR 864.7660
Advisory panel: Hematology
Date received: 1990-08-30
Decision date: 1990-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GHD

view all

K903995 — NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT1990-12-13
K896092 — ALKALINE PHOSPHATASE, LEUKOCYTE, KIT1989-11-09
K811189 — CHEMSTRIP L1981-07-27

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.