510(k) K832496
- Device
- Bio Sure Stain
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K832496
- Product code
- IDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-12
- Date received
- 1983-07-27
- Regulation
- 864.1850
- Classification name
- Alcian Blue
- Medical specialty
- Hematology
- Review panel
- Hematology
- 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#
- 1419699
- 3008174888
- 3009189893
- 2028492
- 2022180
- 3004074729
- 2916205
- 1640981
- 3007496191
- 2013736
- 9610140
- 3009963993
- 1831638
- 1831338
- 3009432145
- 2247035
- 3008776165
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IDA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K801143 | VOLU-SOL URINARY DICHROME STAIN | Volu Sol Medical Industries | 1980-05-30 |