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510(k) K955937

INORGANIC PHOSPHORUS REAGENT by Derma Media Lab., Inc. — Product Code CEO

K955937 is an FDA 510(k) premarket notification submitted by Derma Media Lab., Inc. for the device "INORGANIC PHOSPHORUS REAGENT". The FDA issued a decision of Substantially Equivalent on March 12, 1996. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Derma Media Lab., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1996
Date Received
December 21, 1995
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 Derma Media Lab., Inc.

  • K970664 — GLUCOSE REAGENT (August 1, 1997)
  • K971309 — UREA (August 1, 1997)
  • K971072 — CHOLESTEROL REAGENT (June 20, 1997)
  • K970867 — URIC ACID REAGENT (April 21, 1997)
  • K971005 — TRIGLYCERIDES (April 21, 1997)
  • K964915 — MAGNESIUM (March 26, 1997)
  • K964913 — IRON REAGENT (February 20, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K964914 — ALKALINE PHOSPHATASE (February 4, 1997)
  • K965126 — AST/SGOT (January 17, 1997)

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