FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
K Number: K851362
·
Decision Jun 12, 1985
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
6
Review Days
69
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Basic Information
- Device Name
- STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
- K Number
- K851362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Rna Medical Corp.
- Date Received
- April 4, 1985
- Decision Date
- June 12, 1985
- Product Code
- FKH
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKH | Solution-Test Standard-Conductivity, Dialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKH), ordered by most recent decision date.
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SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.
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Other Clearances by Rna Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K844589 | OSMOLARITY STANDARDS | Mar 1, 1985 | Substantially Equivalent |
| K842131 | FORMACLEAR- & MULTIPLE | Sep 10, 1984 | Substantially Equivalent |
| K842519 | BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 | Aug 17, 1984 | Substantially Equivalent |
| K830843 | BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- | Apr 28, 1983 | Substantially Equivalent |
| K813447 | SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR | Dec 31, 1981 | Substantially Equivalent |