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510(k) K821209

SGOT REAGENT SET by Omega Medical Electronics — Product Code CIQ

K821209 is an FDA 510(k) premarket notification submitted by Omega Medical Electronics for the device "SGOT REAGENT SET". The FDA issued a decision of Substantially Equivalent on July 14, 1982. The device falls under product code CIQ (Diazo, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Omega Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo, 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)
  • K821204 — GLUCOSE(ENZYMATIC) REAGENT SET (July 22, 1982)
  • K821212 — UREA NITROGEN REAGENT SET (July 22, 1982)
  • K821206 — SGPT-UV REAGENT SET (July 22, 1982)
  • K821205 — TRIGLYCERIDE REAGENT SET (July 20, 1982)
  • K821201 — LDH-UV REAGENT SET (July 20, 1982)
  • K821208 — SGOT-UV REAGENT SET (July 20, 1982)
  • K821207 — SGPT REAGENT SET (July 14, 1982)
  • K821196 — SERUM CALCIUM REAGENT SET (July 13, 1982)
  • K821213 — URIC ACID REAGENT SET (July 13, 1982)

Other clearances for product code CIQ

  • K881173 — ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (June 7, 1988)
  • K860216 — SGOT (AST) REAGENT SET (April 3, 1986)
  • K855189 — GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET (January 14, 1986)
  • K844322 — SGOT REAGENT SET (November 27, 1984)
  • K841065 — SGOT REAGENT SET (May 1, 1984)
  • K820466 — SGOT REAGENT SET (March 11, 1982)

FDA data resources