FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MDX 2000, DIGITAL ANALYZER
K Number: K970824
·
Decision May 30, 1997
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
34
Applicant Total
3
Review Days
85
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MDX 2000, DIGITAL ANALYZER
- K Number
- K970824
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5260
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shotwell & Carr, Inc.
- Date Received
- March 6, 1997
- Decision Date
- May 30, 1997
- Product Code
- JOY
- 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 |
|---|---|---|---|
| JOY | Device, Automated Cell-Locating | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOY), ordered by most recent decision date.
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
FDA 510(k)
FDA Class 2
·Hematology
AI100 with Shonit
FDA 510(k)
FDA Class 2
·Hematology
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
FDA 510(k)
FDA Class 2
·Hematology
CellaVision DC-1, CellaVision DC-1 PPA
FDA 510(k)
FDA Class 2
·Hematology
X100 with Full Field Peripheral Blood Smear (PBS) Application
FDA 510(k)
FDA Class 2
·Hematology
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
FDA 510(k)
FDA Class 2
·Hematology