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510(k) K821208

SGOT-UV REAGENT SET by Omega Medical Electronics — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
Review Panel
CH
Submission Type

Other clearances by Omega Medical Electronics

  • K823691 — PHOSPHORUS REAGENT SET (January 7, 1983)
  • K821206 — SGPT-UV REAGENT SET (July 22, 1982)
  • K821212 — UREA NITROGEN REAGENT SET (July 22, 1982)
  • K821204 — GLUCOSE(ENZYMATIC) REAGENT SET (July 22, 1982)
  • K821201 — LDH-UV REAGENT SET (July 20, 1982)
  • K821205 — TRIGLYCERIDE REAGENT SET (July 20, 1982)
  • K821207 — SGPT REAGENT SET (July 14, 1982)
  • K821209 — SGOT REAGENT SET (July 14, 1982)
  • K821195 — CHOLESTEROL REAGENT SET (July 13, 1982)
  • K821193 — ALBUMIN REAGENT SET (July 13, 1982)

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