FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLASMA CATECHOLAMINE KIT
K Number: K972167
·
Decision Aug 4, 1997
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
9
Applicant Total
3
Review Days
56
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
- PLASMA CATECHOLAMINE KIT
- K Number
- K972167
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1165
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioanalytical Systems, Inc.
- Date Received
- June 9, 1997
- Decision Date
- August 4, 1997
- Product Code
- CHQ
- 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 |
|---|---|---|---|
| CHQ | Chromatographic/Fluorometric Method, Catecholamines | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHQ), ordered by most recent decision date.
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ESA PLASMA FREE METANEPHRINE ANALYSIS KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODEL 5500 CEAS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URINARY METANEPHRINE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URINARY CATECHOLAMINE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry