FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTROLYTE ANALYZER SERA-210
K Number: K841424
·
Decision Jun 22, 1984
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
161
Applicant Total
5
Review Days
77
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
- ELECTROLYTE ANALYZER SERA-210
- K Number
- K841424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Horiba Instruments, Inc.
- Date Received
- April 6, 1984
- Decision Date
- June 22, 1984
- Product Code
- JGS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGS), ordered by most recent decision date.
ABL90 FLEX PLUS System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
A-LYTE® Integrated Multisensor (IMT Na K Cl)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLP systems Track
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Stat Profile Prime Plus Analyzer System
FDA 510(k)
FDA Class 2
·Clinical Chemistry