SGOT REAGENT SET— 510(k) K821209

Substantially Equivalent

Omega Medical Electronics

FDA 510(k) clearance K821209 for SGOT REAGENT SET, Substantially Equivalent on 1982-07-14. Applicant: Omega Medical Electronics. Device class: 2.

Clearance details

Applicant: Omega Medical Electronics
Product code: Code CIQ
Device class: Class 2
Regulation: 21 CFR 862.1100
Advisory panel: Clinical Chemistry
Date received: 1982-04-27
Decision date: 1982-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIQ

K881173 — ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)1988-06-07
K860216 — SGOT (AST) REAGENT SET1986-04-03
K855189 — GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET1986-01-14
K844322 — SGOT REAGENT SET1984-11-27
K841065 — SGOT REAGENT SET1984-05-01

More clearances from Omega Medical Electronics

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.