FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VOLU-SOL DECALCIFER
K Number: K822036
·
Decision Aug 3, 1982
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
7
Applicant Total
66
Review Days
22
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Basic Information
- Device Name
- VOLU-SOL DECALCIFER
- K Number
- K822036
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Volu Sol Medical Industries
- Date Received
- July 12, 1982
- Decision Date
- August 3, 1982
- Product Code
- KDX
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| KDX | Solution, Decalcifier, Acid Containing | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDX), ordered by most recent decision date.
DECALCIFYING SOLUTION
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SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E
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DECALCIFIER SOLUTION
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DECALCIFIER I
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FORMICAL
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CAL-RITE
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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 |
| 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 |
| K821540 | HEMATOXYLIN II | Jun 10, 1982 | Substantially Equivalent |