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510(k) K885041

BIOTROL INORGANIC PHOSPHORUS by Biotrol, USA, Inc. — Product Code CEO

K885041 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL INORGANIC PHOSPHORUS". The FDA issued a decision of Substantially Equivalent on January 30, 1989. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1989
Date Received
December 5, 1988
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 Biotrol, USA, Inc.

  • K934014 — VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT (December 6, 1995)
  • K931141 — BIOTROL AMYLASE CNPG3 (May 26, 1993)
  • K921855 — BIOTROL BICARBONATE STANDARDS (August 3, 1992)
  • K921677 — BIOTROL MAGNESIUM (MAGON) (May 26, 1992)
  • K912795 — BIOTROL UIBC REAGENT (August 12, 1991)
  • K910721 — BIOTROL PROTEIN MULTILEVEL STANDARDS (May 6, 1991)
  • K905683 — BIOTROL LACTATE DEHYDROGENASE (L-P) (March 11, 1991)
  • K905280 — BIOTROL BILIRUBIN C & T CONTROL (February 4, 1991)
  • K894544 — BIOTROL RUB-E.I.A. TEST G (August 30, 1989)
  • K891061 — BIOTROL CALCIUM MONOREACTIF (August 10, 1989)

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