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510(k) K945368

PHOSPHORUS TEST (PHOS) by Emd Chemicals, Inc. — Product Code CEO

K945368 is an FDA 510(k) premarket notification submitted by Emd Chemicals, Inc. for the device "PHOSPHORUS TEST (PHOS)". The FDA issued a decision of Substantially Equivalent on Dec 2, 1994. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Emd Chemicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 2, 1994
Date Received
Oct 20, 1994
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 Emd Chemicals, Inc.

  • K031367 — DUOPATH VEROTOXINS GLISA TEST (Jan 23, 2004)
  • K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (Mar 31, 1999)
  • K981926 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (Jul 22, 1998)
  • K973054 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (Oct 1, 1997)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (Dec 11, 1995)
  • K951750 — GLUCOSE TEST ITEM NUMBER 97375/94 (Sep 6, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (Jun 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)
  • K945322 — PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 (Dec 7, 1994)
  • K840883 — UNIPAK 100 ANALYZER, 65156 & CHEMISTR (May 16, 1984)

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 (Jun 24, 2008)
  • K041643 — SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (Aug 18, 2004)
  • K030015 — ATAC PAK PHOSPHORUS REAGENT (Mar 7, 2003)
  • K022312 — PICCOLO PHOSPHORUS TEST SYSTEM (Sep 5, 2002)
  • K013095 — WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 (Nov 16, 2001)
  • K003912 — PHOSPHORUS REAGENT (Feb 21, 2001)
  • K003012 — RAICHEM PHOSPORUS REAGENT (Oct 25, 2000)
  • K991867 — INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (Aug 2, 1999)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (Dec 1, 1998)

FDA data resources