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510(k) K770454

CREATININE PROCEDURE, TEKPOINT by Icn Pharmaceuticals, Inc. — Product Code CGX

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
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Icn Pharmaceuticals, Inc.

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  • K914530 — ICAN GT DRAINAGE BAG (December 18, 1991)
  • K914082 — SUAN FLAT DISSECTOR SPONGES (November 27, 1991)
  • K914083 — ICAN K DISSECTOR SPONGES (October 9, 1991)
  • K914086 — ICAN CYLINDRICAL SPONGES (October 9, 1991)
  • K914081 — ICAN COTTON RAYON BALLS (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)

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