Potassium Hydroxide 10% W/V
FDA 510(k) K863550 · Reagent Laboratory, Inc.
510(k) numberK863550
Submission
- Device name
- Potassium Hydroxide 10% W/V
- Applicant
- Reagent Laboratory, Inc.
Louisville, KY, US - Received
- September 12, 1986
- Decision date
- October 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- PPM – General Purpose Reagent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Specialty
- Pathology
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…
Other 510(k)s with product code PPM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871533 | Tomtec Gram Stainer DecolorizerPPM · Traditional | Remel Co. | 04/29/1987SE |
| K861890 | 100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2PPM · Traditional | Richard-Allan Medical Ind., Inc. | 06/03/1986SE |
| K850916 | SprayfixPPM · Traditional | Surgipath Medical Industries, Inc. | 03/25/1985SE |
| K850845 | 0.85% SalinePPM · Traditional | Micro Media Laboratories | 03/20/1985SE |
| K850737 | Transport Culture MediumPPM · Traditional | Roseville Medical Laboratoriesu | 03/20/1985SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | E K Ind., Inc. | 09/12/1984SE |
| K842863 | Pro-Soft DehydrantPPM · Traditional | Anatech, Ltd. | 08/21/1984SE |
| K842729 | Decolorizing FluidPPM · Traditional | E K Ind., Inc. | 08/03/1984SE |
| K842070 | Idd DetergentPPM · Traditional | Interscience Diagnostics, Inc. | 07/02/1984SE |
| K831620 | Sodium Hypochlorite 3%PPM · Traditional | Omega Medical Diagnostics | 07/28/1983SE |
More from Omega Medical Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K863502 | Solution B- Na 50MEQ/L, K 40 Meq/LJIX · Traditional | 10/21/1986SE |
| K863503 | HemolyseGGK · Traditional | 10/03/1986SE |
| K860143 | Urine Diluent-For Use with Ion Selective ElectrodeJJP · Traditional | 02/10/1986SE |
| K842982 | Formalin BufferedIFP · Traditional | 10/01/1984SE |
| K843050 | Gram StainJTS · Traditional | 09/11/1984SE |
| K842785 | Stain, Methylene Blue-EosinKFC · Traditional | 09/11/1984SE |
| K841847 | Lithium ReagentJJO · Traditional | 08/17/1984SE |
| K843051 | Wrights Stain Solution · Traditional | 08/03/1984SESP |
| K841800 | Lysing & Hemoglobin ReagentGGK · Traditional | 05/31/1984SE |
| K841799 | Cyanomethemoglobin ReagentGIF · Traditional | 05/31/1984SE |
Questions and answers
When was Potassium Hydroxide 10% W/V cleared by the FDA?
Potassium Hydroxide 10% W/V (K863550) received a 510(k) decision of Substantially Equivalent on October 2, 1986, 20 days after the submission was received.
What is the product code of K863550?
The FDA product code is PPM – General Purpose Reagent, a Class I (low risk) device regulated under 21 CFR 864.4010.