Hematoxylin, Iron, Weigert'S
Weigert's Iron Hematoxylin is a progressive nuclear stain used in histology, particularly in combination with other stains such as Van Gieson's, to stain nuclei dark blue-black in tissue sections and is notable for its resistance to destaining. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls only with no premarket notification required. The product code is IAE, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- IAE
- 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 |
|---|---|---|---|---|
| K771524 | HISTOCHEMICAL FERRIC IRON SET | Aug 22, 1977 | Substantially Equivalent | Harleco |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.