FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
K Number: K950221
·
Decision Mar 21, 1995
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
43
Applicant Total
4
Review Days
61
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Basic Information
- Device Name
- MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
- K Number
- K950221
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Izon Business Products, Inc.
- Date Received
- January 19, 1995
- Decision Date
- March 21, 1995
- Product Code
- JXA
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| JXA | Kit, Screening, Urine | FDA class 1 | Microbiology |
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