510(k) K842986
- Device
- REFRAX MOUNTING MEDIUM
- Applicant
- ANATECH, LTD.
- 510(k) number
- K842986
- Product code
- LEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-08-21
- Date received
- 1984-07-30
- Regulation
- 864.4010
- Classification name
- Mounting Media
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004594181
- 2022807
- 3023034117
- 1419968
- 3009963993
- 3013059683
- 3007361513
- 3004140393
- 1640981
- 3003423869
- 2247035
- 3004421347
- 3009189893
- 1063851
- 2083544
- 9610099
- 3010692993
- 3003268355
- 1831638
- 3017170972
- 3004973408
- 1831338
- 1528450
- 3007118747
- 3007496191
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LEB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K821019 | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | Microbiological Research Corp. | 1982-04-26 |
| K812193 | KOH MOUNTING FLUID | American Scientific Products | 1981-08-31 |
| K811799 | CLEAR-MOUNT | Richard-Allan Medical Ind., Inc. | 1981-07-31 |
| K760838 | LACTO-PHENOL COTTON BLUE MOUNTING FL. | I M, Inc. | 1976-11-16 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases