Transport Culture Medium
FDA 510(k) K850737 · Roseville Medical Laboratoriesu
510(k) numberK850737
Submission
- Device name
- Transport Culture Medium
- Applicant
- Roseville Medical Laboratoriesu
Roseville, CA, US - Received
- February 20, 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 |
| K850845 | 0.85% SalinePPM · Traditional | Micro Media Laboratories | 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 |
|---|---|---|
| K850738 | Supplement for Culture MediumJSK · Traditional | 03/20/1985SE |
| K850736 | Selective Culture MediumJSI · Traditional | 03/20/1985SE |
| K850734 | Differential Culture MediumJSE · Traditional | 03/20/1985SE |
| K850733 | Multipurpose Culture MediumJSG · Traditional | 03/20/1985SE |
| K850732 | Culture Medium for Pathogenic Neisseria Ssp.MiJTY · Traditional | 03/20/1985SE |
| K850731 | Culture Medium for Antimicrobial Suscep. TestingJTZ · Traditional | 03/20/1985SE |
| K850735 | Enriched Culture MediumKZI · Traditional | 03/16/1985SE |
Questions and answers
When was Transport Culture Medium cleared by the FDA?
Transport Culture Medium (K850737) received a 510(k) decision of Substantially Equivalent on March 20, 1985, 28 days after the submission was received.
What is the product code of K850737?
The FDA product code is PPM – General Purpose Reagent, a Class I (low risk) device regulated under 21 CFR 864.4010.