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510(k) K821202

HEMOGLOBIN REAGENT SET by Omega Medical Electronics — Product Code GKK

K821202 is an FDA 510(k) premarket notification submitted by Omega Medical Electronics for the device "HEMOGLOBIN REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 24, 1982. The device falls under product code GKK (Cyanomethemoglobin), a Class II device regulated under 21 CFR 864.7500. Omega Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cyanomethemoglobin
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type

Other clearances by Omega Medical Electronics

  • K823691 — PHOSPHORUS REAGENT SET (January 7, 1983)
  • K821212 — UREA NITROGEN REAGENT SET (July 22, 1982)
  • K821204 — GLUCOSE(ENZYMATIC) 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)
  • K821209 — SGOT REAGENT SET (July 14, 1982)
  • K821210 — SERUM TOTAL PROTEIN REAGENT SET (July 13, 1982)

Other clearances for product code GKK

  • K896922 — RAICHEM TM HEMOGLOBIN REAGENT (January 25, 1990)
  • K894951 — MODIFIED HEMOGLOBIN REAGENT SET (October 24, 1989)
  • K883992 — KVM PREPACK HEMATOLOGY REAGENT SET (October 12, 1988)
  • K771716 — CYMET-PLUS (September 20, 1977)
  • K771090 — UNIPAK HEMOGLOBIN (July 11, 1977)
  • K770803 — HEMOTOLOGY PRODU&TS (5 IN ALL) (July 5, 1977)

FDA data resources