FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
2XC MICROSCOPE
K Number: K822207
·
Decision Aug 5, 1982
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
8
Applicant Total
1
Review Days
13
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
- 2XC MICROSCOPE
- K Number
- K822207
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3600
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Amarel Precision Instruments, Inc.
- Date Received
- July 23, 1982
- Decision Date
- August 5, 1982
- Product Code
- IBJ
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| IBJ | Light, Microscope | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IBJ), ordered by most recent decision date.
VIDEO ANALYZER 4000
FDA 510(k)
FDA Class 1
·Pathology
CELL COUNTING GRID GRATICULE
FDA 510(k)
FDA Class 1
·Pathology
THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
FDA 510(k)
FDA Class 1
·Pathology
MCARTHUR MICROSCOPE, STANDARD METAL VERSION
FDA 510(k)
FDA Class 1
·Pathology
MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.
FDA 510(k)
FDA Class 1
·Pathology
PATHOLOGY INSTRUMENTATION & ACCESSORIES
FDA 510(k)
FDA Class 1
·Pathology