FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARA-STAIN MODEL 3000
K Number: K771699
·
Decision Sep 13, 1977
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
20
Applicant Total
7
Review Days
7
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
- CARA-STAIN MODEL 3000
- K Number
- K771699
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3800
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- American Safety Equipment Corp.
- Date Received
- September 6, 1977
- Decision Date
- September 13, 1977
- Product Code
- KPA
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| 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
Other Clearances by American Safety Equipment Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K801010 | KIRSCHNER WIRE | May 20, 1980 | Substantially Equivalent |
| K760956 | SURGICAL MICRO DRILL | Nov 19, 1976 | Substantially Equivalent |
| K760960 | SURGICAL WIRE DRIVER | Nov 19, 1976 | Substantially Equivalent |
| K760958 | SURGICAL OSCILLATING SAW | Nov 16, 1976 | Substantially Equivalent |
| K760957 | SURGICAL RECIPROCATING SAW | Nov 15, 1976 | Substantially Equivalent |
| K760959 | SURGICAL CHISEL | Nov 15, 1976 | Substantially Equivalent |