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510(k) K821198

DIRECT GLUCOSE REAGENT SET by Omega Medical Electronics — Product Code CGE

K821198 is an FDA 510(k) premarket notification submitted by Omega Medical Electronics for the device "DIRECT GLUCOSE REAGENT SET". The FDA issued a decision of Substantially Equivalent on July 13, 1982. The device falls under product code CGE (Orthotoluidine, Glucose), a Class II device regulated under 21 CFR 862.1345. Omega Medical Electronics has at least 10 other 510(k) clearances on record.

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
Orthotoluidine, Glucose
Device Class
Class II
Regulation Number
862.1345
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)
  • K821206 — SGPT-UV REAGENT SET (July 22, 1982)
  • K821212 — UREA NITROGEN 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 CGE

  • K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (February 17, 1989)
  • K855185 — GLUCOSE REAGENT SET (January 22, 1986)
  • K850930 — GLUCOSE (June 10, 1985)
  • K841054 — DIRECT GLUCOSE REAGENT SET (May 1, 1984)
  • K811883 — KING DIAGNOSTICS GLUCOSE-O TEST (July 23, 1981)
  • K810089 — 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI (January 26, 1981)
  • K790319 — ORTHO-TOLUIDINE REAGENT SET (March 21, 1979)
  • K781308 — GLUCOLOUR (August 31, 1978)
  • K771314 — GLUCOSE REAGENT (O-TOLUIDINE) (August 3, 1977)
  • K771091 — UNIPAK GLUCOSE (July 21, 1977)

FDA data resources