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510(k) K983503

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 by Boehringer Mannheim Corp. — Product Code CEO

K983503 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347". The FDA issued a decision of Substantially Equivalent on December 1, 1998. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1998
Date Received
October 6, 1998
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 Boehringer Mannheim Corp.

  • K984326 — ELECYS IGE ASSAY (February 8, 1999)
  • K983047 — ACCU-CHEK HQ SYSTEM (February 5, 1999)
  • K984419 — ELECSYS IGE CALCHECK (February 2, 1999)
  • K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (January 20, 1999)
  • K984372 — ELECSYS CALCHECK TROPONIN T (December 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (December 8, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (November 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K982949 — ELECSYS PSA, MODEL 2010 (October 27, 1998)
  • K983510 — CHEMSTRIP 101 URINE ANALYZER (October 27, 1998)

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

FDA data resources