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510(k) K100263

ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS by Seppim S.A.S. — Product Code CEO

K100263 is an FDA 510(k) premarket notification submitted by Seppim S.A.S. for the device "ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS". The FDA issued a decision of Substantially Equivalent on May 6, 2011. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Seppim S.A.S. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2011
Date Received
January 28, 2010
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 Seppim S.A.S.

  • K103376 — ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYST (November 18, 2011)
  • K100547 — ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR (May 19, 2011)
  • K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL (May 19, 2011)
  • K100525 — ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELIT (December 15, 2010)
  • K093883 — AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250 (September 20, 2010)
  • K832460 — TRIGLYCERIDE REAGENT-TRINDER-GPO (September 12, 1983)

Other clearances for product code CEO

  • 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)
  • K981769 — HICHEM PHOSPHORUS REAGENT KIT (June 29, 1998)

FDA data resources