FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
MICROS 60
K Number: K030799
·
Decision Apr 8, 2003
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
10
Review Days
26
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Basic Information
- Device Name
- MICROS 60
- K Number
- K030799
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abx Diagnostics
- Date Received
- March 13, 2003
- Decision Date
- April 8, 2003
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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Other Clearances by Abx Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K030144 | MODIFICATION TO PENTRA 60 AND PENTRA 60C+ | Jan 31, 2003 | Substantially Equivalent |
| K024002 | PENTRA 80 | Jan 3, 2003 | Substantially Equivalent |
| K022200 | PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 | Jul 29, 2002 | Substantially Equivalent |
| K014203 | ABX MICROS 60 HEMATOLOGY ANALYZER | Feb 28, 2002 | Substantially Equivalent |
| K003677 | ABX PENTRA 60C+ HEMATOLOGY ANALYZER | Dec 26, 2000 | Substantially Equivalent |
| K002646 | ABX MICROS CRP | Oct 26, 2000 | Substantially Equivalent |
| K992511 | ABX PENTRA 60 HEMATOLOGY ANALYZER | Oct 15, 1999 | Substantially Equivalent |
| K991839 | ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER | Aug 11, 1999 | Substantially Equivalent |
| K990311 | VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER | Mar 31, 1999 | Substantially Equivalent |