FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAGENTS & STANDARDS IL 501 NA/K
K Number: K840557
·
Decision Apr 4, 1984
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
161
Applicant Total
35
Review Days
56
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Basic Information
- Device Name
- REAGENTS & STANDARDS IL 501 NA/K
- K Number
- K840557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Shaban Mfg. Co.
- Date Received
- February 8, 1984
- Decision Date
- April 4, 1984
- Product Code
- JGS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Shaban Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K853621 | REPLACEMENT PUMP TUBING | Dec 5, 1985 | Substantially Equivalent |
| K850333 | PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS | Feb 27, 1985 | Substantially Equivalent |
| K850157 | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS | Feb 27, 1985 | Substantially Equivalent |
| K844781 | MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB | Feb 1, 1985 | Substantially Equivalent |
| K844235 | CHLORIDE STANDARD | Nov 20, 1984 | Substantially Equivalent |
| K842656 | REPLACEMENT PARTS NOVA ELECTROLYTE ANAL | Aug 12, 1984 | Substantially Equivalent |
| K841610 | COMPONENTS FOR POTASSIUM, SODIUM CHLO | May 25, 1984 | Substantially Equivalent |
| K841609 | COMPONENTS FOR PARTIAL PRESSURE ELEE | May 25, 1984 | Substantially Equivalent |
| K840468 | PARTIAL PRESS. ELECTRODE MEASUREMENT | Mar 30, 1984 | Substantially Equivalent |
| K840530 | SUPPLIES FOR INSTRUMENTATION LAB FLAME | Mar 30, 1984 | Substantially Equivalent |