FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DECALCIFIER II
K Number: K810836
·
Decision Apr 23, 1981
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
7
Applicant Total
12
Review Days
28
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Basic Information
- Device Name
- DECALCIFIER II
- K Number
- K810836
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Surgipath
- Date Received
- March 26, 1981
- Decision Date
- April 23, 1981
- 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.
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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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VOLU-SOL DECALCIFER
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FORMICAL
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Other Clearances by Surgipath
| K Number | Device Name | ||
|---|---|---|---|
| K820027 | MODIFIED EA 50 | Feb 4, 1982 | Substantially Equivalent |
| K812940 | 10% NEUTRAL BUFFERED FORMALIN CONCENT | Dec 10, 1981 | Substantially Equivalent |
| K812087 | EA 50 | Aug 13, 1981 | Substantially Equivalent |
| K812086 | EA 65 | Aug 13, 1981 | Substantially Equivalent |
| K811825 | ORANGE G-6 | Jul 10, 1981 | Substantially Equivalent |
| K811826 | EOSIN Y | Jul 10, 1981 | Substantially Equivalent |
| K810758 | GILL'S HEMATOXYLIN #1 | Apr 14, 1981 | Substantially Equivalent |
| K810733 | HARRIS HEMATOXYLIN | Apr 14, 1981 | Substantially Equivalent |
| K810759 | GILL'S HEMATOXYLIN #2 | Apr 14, 1981 | Substantially Equivalent |
| K810760 | GILL'S HEMATOXYLIN #3 | Apr 14, 1981 | Substantially Equivalent |