HEMOLYSE— 510(k) K781121

Substantially Equivalent

Electrophoresis Corp. of America

FDA 510(k) clearance K781121 for HEMOLYSE, Substantially Equivalent on 1978-08-14. Applicant: Electrophoresis Corp. of America. Device class: 1.

Clearance details

Applicant: Electrophoresis Corp. of America
Product code: Code GGK
Device class: Class 1
Regulation: 21 CFR 864.8540
Advisory panel: Hematology
Date received: 1978-07-03
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGK

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 Electrophoresis Corp. of America

K802396 — GENERAL PROCEDURE AGAROSE FILM1980-11-26
K792547 — AGAROSE BARBITAL BUFFER1980-01-29
K792548 — ALKALINE PHOSPHATASE MARKER1980-01-29
K792551 — ALKALINE PHOSPHATASE REAGENT1980-01-29
K792553 — AGAROSE BARBITAL-EDTA BUFFER1980-01-29

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