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510(k) K813400

INORGANIC PHOSPHORUS REAGENT SET by Anco Medical Reagents & Assoc. — Product Code CEO

K813400 is an FDA 510(k) premarket notification submitted by Anco Medical Reagents & Assoc. for the device "INORGANIC PHOSPHORUS REAGENT SET". The FDA issued a decision of Substantially Equivalent on December 22, 1981. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Anco Medical Reagents & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1981
Date Received
December 4, 1981
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 Anco Medical Reagents & Assoc.

  • K842440 — SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH (July 27, 1984)
  • K831871 — SICKLE-HEME A/S CONTROLS & A/A CONTROL (July 28, 1983)
  • K821658 — HEMOGLOBIN REAGENT (June 25, 1982)
  • K821526 — ACID PHOSPHATASE REAGENT SET (June 10, 1982)
  • K821102 — MEGNESIUM REAGENT KIT (May 5, 1982)
  • K820951 — ENZYMATIC CHOLESTEROL KIT (April 26, 1982)
  • K820491 — SGPT REAGENT SET (March 11, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)
  • K812837 — ALKALINE PHOSPHATASE REAGENT SET (January 29, 1982)

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