RAICHEM TM HEMOGLOBIN REAGENT— 510(k) K896922

Name: FDA 510(k) clearance K896922
Creator: U.S. Food and Drug Administration
Published: 1990-01-25

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K896922 for RAICHEM TM HEMOGLOBIN REAGENT, Substantially Equivalent on 1990-01-25. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code GKK
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1989-12-11
Decision date: 1990-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKK

view all

K894951 — MODIFIED HEMOGLOBIN REAGENT SET1989-10-24
K883992 — KVM PREPACK HEMATOLOGY REAGENT SET1988-10-12
K821202 — HEMOGLOBIN REAGENT SET1982-05-24
K771716 — CYMET-PLUS1977-09-20
K771090 — UNIPAK HEMOGLOBIN1977-07-11

More clearances from Reagents Applications, Inc.

view all

K982056 — RAICHEM CO2 REAGENT1998-06-24
K972853 — CHOLESTEROL RAPID LIQUID REAGENT1997-09-24
K922904 — RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II1992-07-30
K915191 — RAI-TROL ELEVATED LIPIDS CONTROL1991-12-18
K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT1991-09-25

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