FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAT-3 CATECHOLAMINE ASSAY KIT
K Number: K855214
·
Decision Mar 14, 1986
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
9
Applicant Total
3
Review Days
74
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Basic Information
- Device Name
- CAT-3 CATECHOLAMINE ASSAY KIT
- K Number
- K855214
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1165
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Whale Scientific, Inc.
- Date Received
- December 30, 1985
- Decision Date
- March 14, 1986
- 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 |
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