RED CELL LYSING REAGENT 78N 1915-1— 510(k) K822324

Name: FDA 510(k) clearance K822324
Creator: U.S. Food and Drug Administration
Published: 1982-11-08

Substantially Equivalent

Interscience, Inc.

FDA 510(k) clearance K822324 for RED CELL LYSING REAGENT 78N 1915-1, Substantially Equivalent on 1982-11-08. Applicant: Interscience, Inc.. Device class: 1.

Clearance details

Applicant: Interscience, Inc.
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1982-08-03
Decision date: 1982-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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
K883991 — KVM HEMOGLOBIN LYSING REAGENT1988-10-12
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

More clearances from Interscience, Inc.

view all

K822327 — CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT1982-11-16
K822325 — BLOOD CELL DILUENT 78N 19131982-10-18
K822326 — BLENDED DETERGENT-78N 1912-11982-10-18

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