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510(k) K850930

GLUCOSE by Dilab, Inc. — Product Code CGE

K850930 is an FDA 510(k) premarket notification submitted by Dilab, Inc. for the device "GLUCOSE". The FDA issued a decision of Substantially Equivalent on June 10, 1985. The device falls under product code CGE (Orthotoluidine, Glucose), a Class II device regulated under 21 CFR 862.1345. Dilab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1985
Date Received
March 7, 1985
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 Dilab, Inc.

  • K862530 — RAPID AS LATEX (April 21, 1987)
  • K850931 — ALBUMIN (June 26, 1985)
  • K850936 — TOTAL PROTEINS (June 25, 1985)
  • K850938 — CHOLESTEROL (June 25, 1985)
  • K850934 — PHOSPHORUS (June 25, 1985)
  • K850932 — CREATININE (June 25, 1985)
  • K850933 — URIC ACID (June 25, 1985)
  • K850937 — UREA (June 10, 1985)
  • K850935 — CHLORIDE (June 10, 1985)
  • K850929 — CALCIUM (June 10, 1985)

Other clearances for product code CGE

  • K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (February 17, 1989)
  • K855185 — GLUCOSE REAGENT SET (January 22, 1986)
  • 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)
  • K771091 — UNIPAK GLUCOSE (July 21, 1977)

FDA data resources