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510(k) K910296

PHOSPHORUS (INORGANIC) TEST SYSTEM by Biochemical Trade, Inc. — Product Code CEO

K910296 is an FDA 510(k) premarket notification submitted by Biochemical Trade, Inc. for the device "PHOSPHORUS (INORGANIC) TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 27, 1991. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Biochemical Trade, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1991
Date Received
January 23, 1991
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 Biochemical Trade, Inc.

  • K942958 — CREATINE KINASE MB DETERMINATION (UV) (November 21, 1994)
  • K910635 — TOTAL BILIRUBIN REAGENT SET (May 15, 1991)
  • K905776 — ALBUMIN REAGENT SET (February 26, 1991)
  • K905790 — TOTAL PROTEIN REAGENT SET (February 21, 1991)
  • K905619 — CREATININE (RATE) REAGENT SET (February 13, 1991)
  • K905650 — KINETIC ALKALINE PHOSPHATASE DETERMINATION (February 13, 1991)
  • K905651 — KINETIC AMYLASE DETERMINATION (January 31, 1991)
  • K905649 — GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (January 30, 1991)
  • K905588 — CREATINE KINASE UV REAGENT SET (January 17, 1991)
  • K871547 — ULTRA-VIOLET BUN REAGENT KIT (RATE) (June 22, 1987)

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