FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM
K Number: K934607
·
Decision Mar 28, 1994
Classifications
1
FEI Numbers
107
Registration Numbers
107
Same Product Code
301
Applicant Total
31
Review Days
182
Basic Information
- Device Name
- ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM
- K Number
- K934607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ALKO DIAGNOSTIC CORP.
- Date Received
- September 27, 1993
- Decision Date
- March 28, 1994
- Product Code
- JIX
- 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 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 |