KVM PREPACK HEMATOLOGY REAGENT SET— 510(k) K883992

Name: FDA 510(k) clearance K883992
Creator: U.S. Food and Drug Administration
Published: 1988-10-12

Substantially Equivalent

Kvm Technologies, Inc.

FDA 510(k) clearance K883992 for KVM PREPACK HEMATOLOGY REAGENT SET, Substantially Equivalent on 1988-10-12. Applicant: Kvm Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Kvm Technologies, Inc.
Product code: Code GKK
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1988-09-20
Decision date: 1988-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKK

view all

K896922 — RAICHEM TM HEMOGLOBIN REAGENT1990-01-25
K894951 — MODIFIED HEMOGLOBIN REAGENT SET1989-10-24
K821202 — HEMOGLOBIN REAGENT SET1982-05-24
K771716 — CYMET-PLUS1977-09-20
K771090 — UNIPAK HEMOGLOBIN1977-07-11

More clearances from Kvm Technologies, Inc.

view all

K925666 — THERAPACER 30001993-03-09
K883989 — KVM ISOTONIC FLUSH SOLUTION1988-10-12
K883990 — KVM ISOTONIC DILUENT1988-10-12
K883991 — KVM HEMOGLOBIN LYSING REAGENT1988-10-12

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