510(k) K821503
- Device
- IRIS URINE STAIN
- Applicant
- INTL. REMOTE IMAGING SYSTEMS
- 510(k) number
- K821503
- Product code
- ICF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-06-03
- Date received
- 1982-05-19
- Regulation
- 864.1850
- Classification name
- Crystal Violet For Histology
- Medical specialty
- Hematology
- 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#
- 3007496191
- 1937990
- 8010383
- 9610140
- 1219125
- 1625587
- 3002805583
- 1000138378
- 3006365273
- 1045125
- 3004074729
- 2247035
- 3009189893
- 2250039
- 2022180
- 3010152370
- 1125908
- 3017970519
- 1831638
- 3009432145
- 1711690
- 2916205
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ICF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K864531 | TISSUE GRAM STAIN | Sigma Diagnostics, Inc. | 1986-12-22 |
| K842537 | VON WILLEBRAND FACTOR ANTIGEN SCREEN | American Dade | 1984-10-01 |
| K842730 | GENTIAN VIOLET | E K Ind., Inc. | 1984-08-03 |
| K792495 | VOLU-SOL URINARY SEDIMENT STAIN | Volu Sol Medical Industries | 1979-12-18 |
Legacy Summary#
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FDA Review#
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