Decolorizing Fluic, Acid-Alcohol 3%
FDA 510(k) K842934 · E K Ind., Inc.
510(k) numberK842934
Submission
- Device name
- Decolorizing Fluic, Acid-Alcohol 3%
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 25, 1984
- Decision date
- September 12, 1984
- 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 |
| K863550 | Potassium Hydroxide 10% W/VPPM · Traditional | Reagent Laboratory, Inc. | 10/02/1986SE |
| 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 |
| 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 |
|---|---|---|
| K842931 | Drabkin ReagentKAG · Traditional | 09/21/1984SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | 09/12/1984SE |
| K842935 | Acetic Acid, 5% V/VGGK · Traditional | 09/12/1984SE |
| K842933 | Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional | 09/11/1984SE |
| K842930 | Gomori's Trichrome StainLED · Traditional | 09/11/1984SE |
| K842928 | Jenner Blood StainKJX · Traditional | 09/11/1984SE |
| K842927 | Light Green SF 1%HYS · Traditional | 09/11/1984SE |
| K842926 | Methylene Blue Stain, LoefflerKFC · Traditional | 09/11/1984SE |
Questions and answers
When was Decolorizing Fluic, Acid-Alcohol 3% cleared by the FDA?
Decolorizing Fluic, Acid-Alcohol 3% (K842934) received a 510(k) decision of Substantially Equivalent on September 12, 1984, 49 days after the submission was received.
What is the product code of K842934?
The FDA product code is PPM – General Purpose Reagent, a Class I (low risk) device regulated under 21 CFR 864.4010.