Hematoxylin Weigert'S
Weigert's hematoxylin is an iron-based hematoxylin formulation that produces an intensely stained, highly differentiated nuclear stain resistant to over-differentiation, commonly used as a counterstain in specialized histological procedures such as Masson's trichrome. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYO falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- HYO
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K833424 | VEIGERT'S IRON HEMATOXYLIN STAIN-HT10-79 | Nov 03, 1983 | Substantially Equivalent | Sigma Chemical Co. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.