FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SLIDE STAINERS GLS 360 & 360-1
K Number: K771714
·
Decision Oct 5, 1977
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
0
Applicant Total
69
Review Days
23
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
- SLIDE STAINERS GLS 360 & 360-1
- K Number
- K771714
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3800
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Honeywell, Inc.
- Date Received
- September 12, 1977
- Decision Date
- October 5, 1977
- Product Code
- KEY
- 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 |
|---|---|---|---|
| KEY | Stainer, Tissue, Automated | 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 |