FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VOLU-SOL STAT STAIN
K Number: K792017
·
Decision Oct 30, 1979
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
32
Applicant Total
66
Review Days
21
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
- VOLU-SOL STAT STAIN
- K Number
- K792017
- 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
- October 9, 1979
- Decision Date
- October 30, 1979
- Product Code
- IAF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| IAF | Wright'S Stain | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IAF), ordered by most recent decision date.
WRIGHT-GLEMSA STAIN
FDA 510(k)
FDA Class 1
·Hematology
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
FDA 510(k)
FDA Class 1
·Hematology
HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS
FDA 510(k)
FDA Class 1
·Hematology
CAMCO STAIN PAK
FDA 510(k)
FDA Class 1
·Hematology
HEMATOLOGY STAIN PACK
FDA 510(k)
FDA Class 1
·Hematology
WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S
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 |
| K821541 | HEMATOXYLIN III | Jun 10, 1982 | Substantially Equivalent |