100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2
FDA 510(k) K861890 · Richard-Allan Medical Ind., Inc.
510(k) numberK861890
Submission
- Device name
- 100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2
- Applicant
- Richard-Allan Medical Ind., Inc.
Richland, MI, US - Received
- May 16, 1986
- Decision date
- June 3, 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 |
| K863550 | Potassium Hydroxide 10% W/VPPM · Traditional | Reagent Laboratory, Inc. | 10/02/1986SE |
| 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 |
|---|---|---|
| K931879 | Reflex HTRGCJ · Traditional | 03/24/1994SE |
| K924200 | Reflex(R) EscKNF · Traditional | 02/22/1994SE |
| K926297 | Reflex EsiGEI · Traditional | 10/15/1993SE |
| K924761 | Sterile Endoscopic Dispos Trocars W/Safe ShieldGCJ · Traditional | 04/20/1993SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | 05/03/1990SE |
| K896262 | Titanium Ligating ClipsHBT · Traditional | 01/02/1990SE |
| K890314 | Protector (Surgical Instrument)MMK · Traditional | 02/27/1989SE |
| K873309 | Reflex(Tm) Ca-T Clip ApplierFZP · Traditional | 11/27/1987SE |
| K862404 | Reflex(Tm) Clip ApplierFZP · Traditional | 07/23/1986SE |
| K862223 | Micro Thin* ParaffinKEO · Traditional | 06/17/1986SE |
Questions and answers
When was 100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2 cleared by the FDA?
100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2 (K861890) received a 510(k) decision of Substantially Equivalent on June 3, 1986, 18 days after the submission was received.
What is the product code of K861890?
The FDA product code is PPM – General Purpose Reagent, a Class I (low risk) device regulated under 21 CFR 864.4010.