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510(k) K770453

PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE by Icn Pharmaceuticals, Inc. — Product Code CIO

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
Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

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  • 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 CIO

  • K880177 — ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT (April 5, 1988)
  • K860351 — ALKALINE PHOSPHATASE REAGENT SET (February 11, 1986)
  • K855192 — ALKALINE PHOSPHATASE REAGENT SET (January 14, 1986)
  • K844498 — SANDARE ALKALINE PHOSPHATASE PROCEDURE (December 10, 1984)
  • K844237 — ALKALINE PHOSPHATASE REAGENT SET (November 20, 1984)
  • K841064 — ALKALINE PHOSPHOTASE REAGENT SET (May 1, 1984)
  • K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (January 7, 1983)
  • K821200 — ALKALINE PHOSPHOTASE REAGENT SET (July 13, 1982)
  • K781324 — ALP TEST (August 31, 1978)
  • K772257 — ALKALINE PHOSPHATASE TEST SET (December 22, 1977)