0.85% Saline
FDA 510(k) K850845 · Micro Media Laboratories
510(k) numberK850845
Submission
- Device name
- 0.85% Saline
- Applicant
- Micro Media Laboratories
San Diego, CA, US - Received
- March 1, 1985
- Decision date
- March 20, 1985
- 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 |
| 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 |
|---|---|---|
| K853691 | Tergitol 7 AgarJSI · Traditional | 09/17/1985SE |
| K853690 | Columbiz Blood AgarJSG · Traditional | 09/17/1985SE |
| K851344 | Oxidative Formentive MediumJSH · Traditional | 04/22/1985SE |
| K851348 | Coba AgarJSJ · Traditional | 04/19/1985SE |
| K851347 | Kanamycin-Vancomycin-Laked Blood AgarJSJ · Traditional | 04/19/1985SE |
| K851346 | Phenylalanine AgarJSH · Traditional | 04/19/1985SE |
| K851345 | Purple BrothJSH · Traditional | 04/19/1985SE |
| K851343 | Brom Cresol Purple StarchJSH · Traditional | 04/19/1985SE |
| K850848 | Brain Heart Infusion AgarJSG · Traditional | 03/20/1985SE |
| K850847 | Thioglycolate Medium W/Vitamin KL & HeminJSG · Traditional | 03/20/1985SE |
Questions and answers
When was 0.85% Saline cleared by the FDA?
0.85% Saline (K850845) received a 510(k) decision of Substantially Equivalent on March 20, 1985, 19 days after the submission was received.
What is the product code of K850845?
The FDA product code is PPM – General Purpose Reagent, a Class I (low risk) device regulated under 21 CFR 864.4010.