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510(k) K831619

SODIUM HYPOCHLORITE 7% by Omega Medical Diagnostics — Product Code PPM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1983
Date Received
May 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Purpose Reagent
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

Other clearances by Omega Medical Diagnostics

  • K832182 — LYSING REAGENT (August 12, 1983)
  • K831620 — SODIUM HYPOCHLORITE 3% (July 28, 1983)
  • K831618 — HEMOGLOBIN REAGENT (June 16, 1983)
  • K831617 — DILUENT (June 16, 1983)

Other clearances for product code PPM

  • K871533 — TOMTEC GRAM STAINER DECOLORIZER (April 29, 1987)
  • K863550 — POTASSIUM HYDROXIDE 10% W/V (October 2, 1986)
  • K861890 — 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 (June 3, 1986)
  • K850916 — SPRAYFIX (March 25, 1985)
  • K850737 — TRANSPORT CULTURE MEDIUM (March 20, 1985)
  • K850845 — 0.85% SALINE (March 20, 1985)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842863 — PRO-SOFT DEHYDRANT (August 21, 1984)
  • K842729 — DECOLORIZING FLUID (August 3, 1984)
  • K842070 — IDD DETERGENT (July 2, 1984)