FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROMEDIC CRACKPOT RIA KIT
K Number: K880674
·
Decision Oct 6, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
13
Applicant Total
4
Review Days
230
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Basic Information
- Device Name
- MICROMEDIC CRACKPOT RIA KIT
- K Number
- K880674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Icn Micromedic Systems
- Date Received
- February 19, 1988
- Decision Date
- October 6, 1988
- Product Code
- KLN
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| KLN | Radioimmunoassay, Cocaine Metabolite | FDA class 2 | Clinical Toxicology |
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