FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MST-1050-II X-RAY UNIT
K Number: K853210
·
Decision Oct 10, 1985
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
20
Applicant Total
4
Review Days
71
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
- MST-1050-II X-RAY UNIT
- K Number
- K853210
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3800
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Radiological Engineering, Inc.
- Date Received
- July 31, 1985
- Decision Date
- October 10, 1985
- Product Code
- KPA
- Advisory Committee
- Pathology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KPA | Slide Stainer, Automated | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPA), ordered by most recent decision date.
PROFIBLOT
FDA 510(k)
FDA Class 1
·Pathology
VERSABLOT
FDA 510(k)
FDA Class 1
·Pathology
WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
FDA 510(k)
FDA Class 1
·Pathology
LX-100 SLIDE STAINER
FDA 510(k)
FDA Class 1
·Pathology
WESBLOT PROCESSOR
FDA 510(k)
FDA Class 1
·Pathology
SAKURA DRS-60 AUTOMATIC SLIDE STAINER
FDA 510(k)
FDA Class 1
·Pathology