FDA 510(k)

POTASSIUM HYDROXIDE 10% W/V

K-Number: K863550 · 1986-10-02

Decision Date1986-10-02

Product CodePPM

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

POTASSIUM HYDROXIDE 10% W/V is the device name listed in this FDA 510(k) record. The listed applicant is Reagent Laboratory, Inc.. It received FDA 510(k) clearance on 1986-10-02 under 510(k) number K863550. The device is classified under product code PPM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POTASSIUM HYDROXIDE 10% W/V?

POTASSIUM HYDROXIDE 10% W/V is a medical device that received FDA 510(k) clearance on 1986-10-02. The listed applicant is Reagent Laboratory, Inc.. The 510(k) number is K863550.

When did POTASSIUM HYDROXIDE 10% W/V receive FDA 510(k) clearance?

POTASSIUM HYDROXIDE 10% W/V received FDA 510(k) clearance on 1986-10-02, under 510(k) number K863550.

Who is the listed applicant for POTASSIUM HYDROXIDE 10% W/V?

The FDA 510(k) record lists Reagent Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POTASSIUM HYDROXIDE 10% W/V?

The FDA product code for POTASSIUM HYDROXIDE 10% W/V is PPM.

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Other records listing Reagent Laboratory, Inc. as applicant

K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/L K863503HEMOLYSE K860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE K842982FORMALIN BUFFERED K843050GRAM STAIN K842785STAIN, METHYLENE BLUE-EOSIN

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Related Devices (Code: PPM)

K871533TOMTEC GRAM STAINER DECOLORIZERRemel Co.K861890100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2Richard-Allan Medical Ind., Inc.K850916SPRAYFIXSurgipath Medical Industries, Inc.K8508450.85% SALINEMicro Media Laboratories K850737TRANSPORT CULTURE MEDIUMRoseville Medical Laboratoriesu K842934DECOLORIZING FLUIC, ACID-ALCOHOL 3%E K Ind., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.