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510(k) K991867

INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 by A.P. Total Care, Inc. — Product Code CEO

K991867 is an FDA 510(k) premarket notification submitted by A.P. Total Care, Inc. for the device "INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02". The FDA issued a decision of Substantially Equivalent on August 2, 1999. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. A.P. Total Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1999
Date Received
June 1, 1999
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 A.P. Total Care, Inc.

  • K991246 — FRUCTOSAMINE, MODEL FR 106-01 (December 16, 1999)
  • K991762 — ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 (September 2, 1999)
  • K991761 — MAGNESIUM PRODUCT NO'S, 112-01, 112-02 (September 2, 1999)
  • K991664 — LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (August 19, 1999)
  • K991665 — HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 (August 10, 1999)
  • K991866 — BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 (August 2, 1999)
  • K991870 — ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03 (July 30, 1999)
  • K991663 — AST/SGOT (June 30, 1999)
  • K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (June 30, 1999)
  • K991244 — TOTAL IRON, MODELS FE 109-01, FE 109-02 (May 25, 1999)

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)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)
  • K981769 — HICHEM PHOSPHORUS REAGENT KIT (June 29, 1998)

FDA data resources