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510(k) K850938

CHOLESTEROL by Dilab, Inc. — Product Code CGO

K850938 is an FDA 510(k) premarket notification submitted by Dilab, Inc. for the device "CHOLESTEROL". The FDA issued a decision of Substantially Equivalent on June 25, 1985. The device falls under product code CGO (Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Dilab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
March 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
Device Class
Class I
Regulation Number
862.1175
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)
  • K850934 — PHOSPHORUS (June 25, 1985)
  • K850932 — CREATININE (June 25, 1985)
  • K850933 — URIC ACID (June 25, 1985)
  • K850937 — UREA (June 10, 1985)
  • K850930 — GLUCOSE (June 10, 1985)
  • K850935 — CHLORIDE (June 10, 1985)
  • K850929 — CALCIUM (June 10, 1985)

Other clearances for product code CGO

  • K811747 — KING DIAGNOSTICS CHOLESTEROL TEST (July 10, 1981)
  • K810090 — CHOLESTEROL REAGENT (January 26, 1981)
  • K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM (May 28, 1980)
  • K781611 — CHOLESTEROL DET. IN SERUM (October 24, 1978)
  • K780545 — SR-PLUS DIRECT CHOLESTEROL TEST (May 26, 1978)
  • K772043 — ALPHA/CHOL (November 28, 1977)
  • K771833 — CHOLESTEROL (October 18, 1977)
  • K771313 — CHOLESTEROL REAGENT (August 3, 1977)
  • K771093 — UNIPAK CHOLESTEROL (July 21, 1977)
  • K770457 — CHOLESTEROL PROCEDURE, TEKPOINT TOTAL (May 3, 1977)

FDA data resources