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510(k) K781308

GLUCOLOUR by Analytical & Research Chemicals, Inc. — Product Code CGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
July 28, 1978
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 Analytical & Research Chemicals, Inc.

  • K823806 — DIRECT CREATININE PROCEDURE (January 14, 1983)
  • K823784 — ENZYMATIC CHOLESTEROL (COLORIMETRIC (January 14, 1983)
  • K823786 — ALKALINE PHOSPHATASE (January 14, 1983)
  • K781441 — BCG ALBUMIN REAGET (October 10, 1978)
  • K781460 — CHLORIDE REAGENT (October 10, 1978)
  • K781323 — LDH PROCEDURE (August 31, 1978)
  • K781306 — UREA NITROGEN TEST KIT (August 31, 1978)
  • K781307 — GLUCOSE DETERM. KIT (August 31, 1978)
  • K781324 — ALP TEST (August 31, 1978)
  • K781305 — UREA NITROGEN (August 31, 1978)

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)
  • K771314 — GLUCOSE REAGENT (O-TOLUIDINE) (August 3, 1977)
  • K771091 — UNIPAK GLUCOSE (July 21, 1977)