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510(k) K863550

POTASSIUM HYDROXIDE 10% W/V by Reagent Laboratory, Inc. — Product Code PPM

K863550 is an FDA 510(k) premarket notification submitted by Reagent Laboratory, Inc. for the device "POTASSIUM HYDROXIDE 10% W/V". The FDA issued a decision of Substantially Equivalent on October 2, 1986. The device falls under product code PPM (General Purpose Reagent), a Class I device regulated under 21 CFR 864.4010. Reagent Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1986
Date Received
September 12, 1986
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 Reagent Laboratory, Inc.

  • K863502 — SOLUTION B- NA 50MEQ/L, K 40 MEQ/L (October 21, 1986)
  • K863503 — HEMOLYSE (October 3, 1986)
  • K860143 — URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE (February 10, 1986)
  • K842982 — FORMALIN BUFFERED (October 1, 1984)
  • K843050 — GRAM STAIN (September 11, 1984)
  • K842785 — STAIN, METHYLENE BLUE-EOSIN (September 11, 1984)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K843051 — WRIGHTS STAIN SOLUTION (August 3, 1984)
  • K841799 — CYANOMETHEMOGLOBIN REAGENT (May 31, 1984)
  • K841800 — LYSING & HEMOGLOBIN REAGENT (May 31, 1984)

Other clearances for product code PPM

  • K871533 — TOMTEC GRAM STAINER DECOLORIZER (April 29, 1987)
  • 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)
  • K831619 — SODIUM HYPOCHLORITE 7% (July 28, 1983)

FDA data resources