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510(k) K770457

CHOLESTEROL PROCEDURE, TEKPOINT TOTAL by Icn Pharmaceuticals, Inc. — Product Code CGO

K770457 is an FDA 510(k) premarket notification submitted by Icn Pharmaceuticals, Inc. for the device "CHOLESTEROL PROCEDURE, TEKPOINT TOTAL". The FDA issued a decision of Substantially Equivalent on May 3, 1977. The device falls under product code CGO (Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Icn Pharmaceuticals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1977
Date Received
March 8, 1977
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 Icn Pharmaceuticals, Inc.

  • K022817 — COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM (November 22, 2002)
  • K951329 — IMMUCHEM GAL-MW EA (November 9, 1995)
  • K914530 — ICAN GT DRAINAGE BAG (December 18, 1991)
  • K914082 — SUAN FLAT DISSECTOR SPONGES (November 27, 1991)
  • K914086 — ICAN CYLINDRICAL SPONGES (October 9, 1991)
  • K914081 — ICAN COTTON RAYON BALLS (October 9, 1991)
  • K914083 — ICAN K DISSECTOR SPONGES (October 9, 1991)
  • K913446 — ICAN NEEDLE COUNTERS (September 13, 1991)
  • K904398 — WATER COLUMN RELIEF VALVE (July 9, 1991)
  • K770458 — BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. (May 10, 1977)

Other clearances for product code CGO

  • K850938 — CHOLESTEROL (June 25, 1985)
  • 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)

FDA data resources