FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRODE, ION SPECIFIC
K Number: K915675
·
Decision Apr 29, 1992
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
28
Applicant Total
31
Review Days
132
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Basic Information
- Device Name
- ELECTRODE, ION SPECIFIC
- K Number
- K915675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alko Diagnostic Corp.
- Date Received
- December 19, 1991
- Decision Date
- April 29, 1992
- Product Code
- JFP
- 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 |
|---|---|---|---|
| JFP | Electrode, Ion Specific, Calcium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Alko Diagnostic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001484 | CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 | Jun 19, 2000 | Substantially Equivalent |
| K982501 | ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 | Sep 1, 1998 | Substantially Equivalent |
| K972004 | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS | Jun 16, 1997 | Substantially Equivalent |
| K970921 | STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) | Apr 8, 1997 | Substantially Equivalent |
| K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | Dec 18, 1996 | Substantially Equivalent |
| K963734 | ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS | Oct 24, 1996 | Substantially Equivalent |
| K960085 | ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS | Mar 11, 1996 | Substantially Equivalent |
| K955154 | CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT | Dec 11, 1995 | Substantially Equivalent |
| K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | Jul 24, 1995 | Substantially Equivalent |
| K950902 | ALKO TONOMETERED SALINE CONTROL | Mar 30, 1995 | Substantially Equivalent |