FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRISPEC URINE CHEMISTRY CONTROL PART A AND B
K Number: K945913
·
Decision Apr 5, 1995
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
3
Review Days
124
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Basic Information
- Device Name
- IRISPEC URINE CHEMISTRY CONTROL PART A AND B
- K Number
- K945913
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- International Remote Imaging Systems
- Date Received
- December 2, 1994
- Decision Date
- April 5, 1995
- Product Code
- JJW
- 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 |
|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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