FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOFLUOR SYSTEM
K Number: K800698
·
Decision May 28, 1980
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
3
Review Days
61
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
- AUTOFLUOR SYSTEM
- K Number
- K800698
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- California Immuno Diagnostic, Inc.
- Date Received
- March 28, 1980
- Decision Date
- May 28, 1980
- Product Code
- JZT
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZT | Fluorometer | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZT), ordered by most recent decision date.
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
FDA 510(k)
FDA Class 1
·Immunology
QLIA IMMUNOCHEMISTRY SYSTEM
FDA 510(k)
FDA Class 1
·Immunology
STAT-20 FLUOROMETER
FDA 510(k)
FDA Class 1
·Immunology
FLUORESCENCE CONCENTRATION ANALYZER (FCA)
FDA 510(k)
FDA Class 1
·Immunology
THE FIAX 5000 FLUOROMETER
FDA 510(k)
FDA Class 1
·Immunology
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
FDA 510(k)
FDA Class 1
·Immunology