HEMOTOLOGY PRODU&TS (5 IN ALL)— 510(k) K770803

Substantially Equivalent

Hycel, Inc.

FDA 510(k) clearance K770803 for HEMOTOLOGY PRODU&TS (5 IN ALL), Substantially Equivalent on 1977-07-05. Applicant: Hycel, Inc.. Device class: 2.

Clearance details

Applicant: Hycel, Inc.
Product code: Code GKK
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1977-05-02
Decision date: 1977-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKK

K896922 — RAICHEM TM HEMOGLOBIN REAGENT1990-01-25
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

More clearances from Hycel, Inc.

K802422 — HYCEL TRIGYCERIDE II TEST1980-10-06
K790335 — HYCEL M1979-02-27
K782116 — KETOSTEROID TEST, HYCEL-171979-01-26
K782176 — HYCEL LDH-INT TEST1979-01-26
K782100 — HYCEL COUNTER 3331979-01-03

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