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510(k) K771091

UNIPAK GLUCOSE by Harleco — Product Code CGE

K771091 is an FDA 510(k) premarket notification submitted by Harleco for the device "UNIPAK GLUCOSE". The FDA issued a decision of Substantially Equivalent on July 21, 1977. The device falls under product code CGE (Orthotoluidine, Glucose), a Class II device regulated under 21 CFR 862.1345. Harleco has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1977
Date Received
June 16, 1977
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 Harleco

  • K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056) (February 12, 1982)
  • K813427 — ULTRACHEM GLUC-DH (December 31, 1981)
  • K813038 — ULTRACHEM TP, ITEM #64974 (November 10, 1981)
  • K813043 — ULTRACHEM CREA ITEM #64972 (November 10, 1981)
  • K813044 — ULTRACHEM ALB, ITEM #64970 (November 10, 1981)
  • K813041 — ULTRAZYME-GT, ITEM #64959 & 65032 (November 10, 1981)
  • K813042 — ULTRACHEM GLUC-DH SET, ITEM #65048 (November 10, 1981)
  • K813040 — ULTRACHEM CA, ITEM #64975 (November 10, 1981)
  • K813039 — ULTRACHEM E-CHOL, ITEM #65025 (November 10, 1981)
  • K812594 — ULTRA ZYME PLUS AMYL #64982 & 65031 (October 2, 1981)

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)
  • K821198 — DIRECT GLUCOSE REAGENT SET (July 13, 1982)
  • 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)

FDA data resources