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510(k) K821199

CREATININE REAGENT SET by Omega Medical Electronics — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
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)
  • K821204 — GLUCOSE(ENZYMATIC) REAGENT SET (July 22, 1982)
  • K821212 — UREA NITROGEN REAGENT SET (July 22, 1982)
  • K821208 — SGOT-UV REAGENT SET (July 20, 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)
  • K821198 — DIRECT GLUCOSE REAGENT SET (July 13, 1982)

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