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510(k) K874038

MULTICHEM INORGANIC PHOSPHOROUS S0923 by Simmler, Inc. — Product Code CEO

K874038 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "MULTICHEM INORGANIC PHOSPHOROUS S0923". The FDA issued a decision of Substantially Equivalent on Oct 28, 1987. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Simmler, Inc. has 22 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 28, 1987
Date Received
Oct 5, 1987
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
510(k) Exempt

Other clearances by Simmler, Inc.

  • K895745 — SICKLE CELL SOLUBILITY TEST KIT (Nov 29, 1989)
  • K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (Feb 11, 1988)
  • K874595 — MULTICHEM (R) MAGNESIUM REAGENT (Jan 21, 1988)
  • K874820 — MULTICHEM HDL PRECIPITATING REAGENT #S0914 (Jan 7, 1988)
  • K874812 — MULTICHEM CHLORIDE REAGENT S0933 (Dec 18, 1987)
  • K874311 — MULTICHEM (R) TOTAL BILIRUBIN (Nov 25, 1987)
  • K874049 — MULTICHEM ALBUMIN REAGENT S0902 (Oct 29, 1987)
  • K873725 — MULTICHEM CREATININE REAGENT S0917 (Oct 20, 1987)
  • K873761 — MULTICHEM ALKALINE PHOSPHATASE (S0903) (Oct 7, 1987)
  • K873697 — MULTICHEM CALCIUM S0910 (Oct 2, 1987)

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

Source: FDA 510(k) database entry for K874038. Report a data issue: hello@regdatalab.com.