510(k) K833273
- Device
- Masson Trichrome Stain Ht15
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K833273
- Product code
- ICN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-31
- Date received
- 1983-09-21
- Regulation
- 864.1850
- Classification name
- Biebrich Scarlet
- 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#
- 2247035
- 1831638
- 3004074729
- 2013736
- 1219125
- 1640981
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ICN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822128 | VOLU-SOL SINGLE DIFFERENTIAL STAIN | Volu Sol Medical Industries | 1982-08-05 |