FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTO. SLIDE STAINER
K Number: K780017
·
Decision Jan 30, 1978
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
20
Applicant Total
69
Review Days
27
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
- AUTO. SLIDE STAINER
- K Number
- K780017
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3800
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Honeywell, Inc.
- Date Received
- January 3, 1978
- Decision Date
- January 30, 1978
- 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 Honeywell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902230 | COLORADO COLOR IMAGING RECORDER | Jun 19, 1990 | Substantially Equivalent |
| K863100 | CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR | Feb 3, 1987 | Substantially Equivalent |
| K853501 | HONEYWELL ELECTRONIC VENTILATOR EV-A | Apr 4, 1986 | Substantially Equivalent |
| K855125 | PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM | Mar 26, 1986 | Substantially Equivalent |
| K851888 | APM DISPOS. BLOOD PRESSURE TRANSDUCER | Aug 6, 1985 | Substantially Equivalent |
| K851496 | ECG MONITOR MODEL RM102 | Jul 24, 1985 | Substantially Equivalent |
| K850794 | PATIENT MONITOR MODEL RM-300 | Apr 18, 1985 | Substantially Equivalent |
| K851092 | PORTABLE DEFIBRILLATOR/MONITOR ED 425 | Apr 10, 1985 | Substantially Equivalent |
| K834530 | EXTENSION BOX EB200 | Jun 1, 1984 | Substantially Equivalent |
| K834282 | ULTRA IMAGER 2000 | Apr 23, 1984 | Substantially Equivalent |