FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMATOXYLIN III
K Number: K821541
·
Decision Jun 10, 1982
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
13
Applicant Total
66
Review Days
17
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEMATOXYLIN III
- K Number
- K821541
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Volu Sol Medical Industries
- Date Received
- May 24, 1982
- Decision Date
- June 10, 1982
- Product Code
- HYJ
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HYJ | Hematoxylin | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HYJ), ordered by most recent decision date.
ANATECH HEMATOXYLIN-NORMAL STRENGTH
FDA 510(k)
FDA Class 1
·Hematology
ANATECH HEMATOXYLIN-EXTRA STRENGTH
FDA 510(k)
FDA Class 1
·Hematology
DELAFIELD HEMATOXYLIN STAIN
FDA 510(k)
FDA Class 1
·Hematology
GILL HEMATOXYLIN STAIN
FDA 510(k)
FDA Class 1
·Hematology
HEMATOXYLIN GILL FORMULATION IX#56016
FDA 510(k)
FDA Class 1
·Hematology
HEMATOXYLIN STAIN SOLUTION
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Volu Sol Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K822126 | VOLU-SOL CARNOY FLUID | Aug 5, 1982 | Substantially Equivalent |
| K822128 | VOLU-SOL SINGLE DIFFERENTIAL STAIN | Aug 5, 1982 | Substantially Equivalent |
| K822127 | VOLU-SOL ZENKERS FIXATIVE | Aug 5, 1982 | Substantially Equivalent |
| K822129 | VOLU-SOL BOVINS FIXATIVE | Aug 5, 1982 | Substantially Equivalent |
| K822036 | VOLU-SOL DECALCIFER | Aug 3, 1982 | Substantially Equivalent |
| K822035 | VOLU-SOL GILLS EA | Aug 3, 1982 | Substantially Equivalent |
| K822038 | VOLU-SOL ORANGE G-6(GILLS-MOD | Aug 3, 1982 | Substantially Equivalent |
| K822037 | VOLU-SOL TAP WATER SUBSTITUTE | Aug 3, 1982 | Substantially Equivalent |
| K812906 | ELVI BICLOT 816 | Jul 22, 1982 | Substantially Equivalent |
| K821540 | HEMATOXYLIN II | Jun 10, 1982 | Substantially Equivalent |