Home / 510(k) Clearances / K850934

510(k) K850934

PHOSPHORUS by Dilab, Inc. — Product Code CEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
March 7, 1985
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 Dilab, Inc.

  • K862530 — RAPID AS LATEX (April 21, 1987)
  • K850931 — ALBUMIN (June 26, 1985)
  • K850938 — CHOLESTEROL (June 25, 1985)
  • K850932 — CREATININE (June 25, 1985)
  • K850936 — TOTAL PROTEINS (June 25, 1985)
  • K850933 — URIC ACID (June 25, 1985)
  • K850935 — CHLORIDE (June 10, 1985)
  • K850937 — UREA (June 10, 1985)
  • K850930 — GLUCOSE (June 10, 1985)
  • K850929 — CALCIUM (June 10, 1985)

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)