Phosphate Buffered Clycerol Mounting Flu
FDA 510(k) K821019 · Microbiological Research Corp.
510(k) numberK821019
Submission
- Device name
- Phosphate Buffered Clycerol Mounting Flu
- Applicant
- Microbiological Research Corp.
Mchenry, IL, US - Received
- April 12, 1982
- Decision date
- April 26, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code LEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K842986 | Refrax Mounting MediumLEB · Traditional | Anatech, Ltd. | 08/21/1984SE |
| K812193 | Koh Mounting FluidLEB · Traditional | American Scientific Products | 08/31/1981SE |
| K811799 | Clear-MountLEB · Traditional | Richard-Allan Medical Ind., Inc. | 07/31/1981SE |
| K760838 | Lacto-Phenol Cotton Blue Mounting Fl.LEB · Traditional | I M, Inc. | 11/16/1976SE |
More from I M, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883011 | MRI Neo-Tryp Trypsin RiaJNO · Traditional | 04/26/1989SE |
| K861123 | The Golden Quad Test (CMV)GQI · Traditional | 02/02/1987SE |
| K861122 | The Golden Quad Test (Toxo)LJK · Traditional | 02/02/1987SE |
| K861121 | The Golden Quad Test (Ebv)GNP · Traditional | 02/02/1987SE |
| K861120 | The Golden Quad Test (HSV)GQO · Traditional | 02/02/1987SE |
| K860450 | The Cmv-Igm TestLKQ · Traditional | 05/13/1986SE |
| K843138 | CMV TestLIN · Traditional | 01/29/1985SE |
| K821018 | Antihuman Igg Globulin Fitc LabeledDEW · Traditional | 04/29/1982SE |
| K803175 | Rubella Virus Serological ReagentsLFX · Traditional | 01/29/1981SE |
| K803134 | Toxoplasma Gondii Serological ReagentsGLZ · Traditional | 01/29/1981SE |
Questions and answers
When was Phosphate Buffered Clycerol Mounting Flu cleared by the FDA?
Phosphate Buffered Clycerol Mounting Flu (K821019) received a 510(k) decision of Substantially Equivalent on April 26, 1982, 14 days after the submission was received.
What is the product code of K821019?
The FDA product code is LEB – Mounting Media, a Class I (low risk) device regulated under 21 CFR 864.4010.