Refrax Mounting Medium
FDA 510(k) K842986 · Anatech, Ltd.
510(k) numberK842986
Submission
- Device name
- Refrax Mounting Medium
- Applicant
- Anatech, Ltd.
Mchenry, IL, US - Received
- July 30, 1984
- Decision date
- August 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code LEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K821019 | Phosphate Buffered Clycerol Mounting FluLEB · Traditional | Microbiological Research Corp. | 04/26/1982SE |
| 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 |
|---|---|---|
| K882874 | Zinc FormalinLDX · Traditional | 07/28/1988SE |
| K882873 | Fieldtex HematoxylinKQC · Traditional | 07/28/1988SE |
| K882268 | Zinc Formalin ConcentrateIGG · Traditional | 06/15/1988SE |
| K881282 | XyleneKEM · Traditional | 04/05/1988SE |
| K872663 | Dry-FormIFP · Traditional | 08/06/1987SE |
| K872500 | Anatech Hematoxylin-Extra StrengthHYJ · Traditional | 07/09/1987SE |
| K872499 | Anatech Hematoxylin-Normal StrengthHYJ · Traditional | 07/09/1987SE |
| K872498 | Harris HematoxylinHYK · Traditional | 07/09/1987SE |
| K870852 | NBF 10% Neutral Buffered FormalinIFP · Traditional | 03/31/1987SE |
| K842940 | Cba FormalinIFP · Traditional | 08/28/1984SE |
Questions and answers
When was Refrax Mounting Medium cleared by the FDA?
Refrax Mounting Medium (K842986) received a 510(k) decision of Substantially Equivalent on August 21, 1984, 22 days after the submission was received.
What is the product code of K842986?
The FDA product code is LEB – Mounting Media, a Class I (low risk) device regulated under 21 CFR 864.4010.