HEMOGLOBIN REAGENT SET— 510(k) K821202

Name: FDA 510(k) clearance K821202
Creator: U.S. Food and Drug Administration
Published: 1982-05-24

Substantially Equivalent

Omega Medical Electronics

FDA 510(k) clearance K821202 for HEMOGLOBIN REAGENT SET, Substantially Equivalent on 1982-05-24. Applicant: Omega Medical Electronics. Device class: 2.

Clearance details

Applicant: Omega Medical Electronics
Product code: Code GKK
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1982-04-27
Decision date: 1982-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code GKK

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K896922 — RAICHEM TM HEMOGLOBIN REAGENT1990-01-25
K894951 — MODIFIED HEMOGLOBIN REAGENT SET1989-10-24
K883992 — KVM PREPACK HEMATOLOGY REAGENT SET1988-10-12
K771716 — CYMET-PLUS1977-09-20
K771090 — UNIPAK HEMOGLOBIN1977-07-11

More clearances from Omega Medical Electronics

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K823691 — PHOSPHORUS REAGENT SET1983-01-07
K821204 — GLUCOSE(ENZYMATIC) REAGENT SET1982-07-22
K821206 — SGPT-UV REAGENT SET1982-07-22
K821212 — UREA NITROGEN REAGENT SET1982-07-22
K821201 — LDH-UV REAGENT SET1982-07-20

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