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510(k) K770456

PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT by Icn Pharmaceuticals, Inc. — Product Code CEO

K770456 is an FDA 510(k) premarket notification submitted by Icn Pharmaceuticals, Inc. for the device "PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT". The FDA issued a decision of Substantially Equivalent on May 3, 1977. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. 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
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device Class
Class I
Regulation Number
862.1580
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)
  • K914081 — ICAN COTTON RAYON BALLS (October 9, 1991)
  • K914086 — ICAN CYLINDRICAL SPONGES (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 CEO

  • K100263 — ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (May 6, 2011)
  • K072141 — S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (June 24, 2008)
  • K041643 — SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (August 18, 2004)
  • K030015 — ATAC PAK PHOSPHORUS REAGENT (March 7, 2003)
  • K022312 — PICCOLO PHOSPHORUS TEST SYSTEM (September 5, 2002)
  • K013095 — WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (November 16, 2001)
  • K003912 — PHOSPHORUS REAGENT (February 21, 2001)
  • K003012 — RAICHEM PHOSPORUS REAGENT (October 25, 2000)
  • K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (August 2, 1999)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)

FDA data resources