Home / 510(k) Clearances / K981769

510(k) K981769

HICHEM PHOSPHORUS REAGENT KIT by Elan Pharma, Inc. — Product Code CEO

K981769 is an FDA 510(k) premarket notification submitted by Elan Pharma, Inc. for the device "HICHEM PHOSPHORUS REAGENT KIT". The FDA issued a decision of Substantially Equivalent on June 29, 1998. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Elan Pharma, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1998
Date Received
May 19, 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 Elan Pharma, Inc.

  • K982469 — HICHEM CHOLESTEROL REAGENT KIT (August 19, 1998)
  • K962247 — HICHEM CK/NAC REAGENT KIT (August 15, 1996)
  • K960115 — HICHEM BUN/UREA REAGENT KIT (March 29, 1996)

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