510(k) K863550

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

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)
K842785 — STAIN, METHYLENE BLUE-EOSIN (September 11, 1984)
K843050 — GRAM STAIN (September 11, 1984)
K841847 — LITHIUM REAGENT (August 17, 1984)
K843051 — WRIGHTS STAIN SOLUTION (August 3, 1984)
K841800 — LYSING & HEMOGLOBIN REAGENT (May 31, 1984)
K841799 — CYANOMETHEMOGLOBIN 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)
K850845 — 0.85% SALINE (March 20, 1985)
K850737 — TRANSPORT CULTURE MEDIUM (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)
K831620 — SODIUM HYPOCHLORITE 3% (July 28, 1983)