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510(k) K981610

CARESIDE ANALYZER by Careside, Inc. — Product Code CEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1998
Date Received
April 30, 1998
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 Careside, Inc.

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  • K020486 — CARESIDE GGT (July 1, 2002)
  • K020487 — CARESIDE ALT (June 4, 2002)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K002792 — CARESIDE CHOLINESTERASE (November 8, 2000)
  • K001462 — CARESIDE HEMOGLOBIN (August 21, 2000)
  • K993771 — CARESIDE DIRECT BILIRUBIN (December 27, 1999)
  • K993634 — CARESIDE ANALYZER (December 2, 1999)
  • K992475 — CARESIDE CO2, TOTAL (September 15, 1999)
  • K991717 — CARESIDE MG (August 10, 1999)

Other clearances for product code CEO

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  • 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)