510(k) K760838
- Device
- Lacto-phenol Cotton Blue Mounting Fl.
- Applicant
- I M, INC.
- 510(k) number
- K760838
- Product code
- LEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-11-16
- Date received
- 1976-10-13
- 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 |
|---|---|---|---|
| K842986 | REFRAX MOUNTING MEDIUM | Anatech, Ltd. | 1984-08-21 |
| 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 |