KVM HEMOGLOBIN LYSING REAGENT— 510(k) K883991

Name: FDA 510(k) clearance K883991
Creator: U.S. Food and Drug Administration
Published: 1988-10-12

Substantially Equivalent

Kvm Technologies, Inc.

FDA 510(k) clearance K883991 for KVM HEMOGLOBIN LYSING REAGENT, Substantially Equivalent on 1988-10-12. Applicant: Kvm Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Kvm Technologies, Inc.
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
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 GGK

view all

K883836 — COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II1988-11-30
K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT1987-10-20
K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.1987-09-09
K863114 — PIASTRINIT1986-11-06
K863503 — HEMOLYSE1986-10-03

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
K883992 — KVM PREPACK HEMATOLOGY REAGENT SET1988-10-12

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