FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UROPAPER EIKEN 6B
K Number: K932368
·
Decision Jan 13, 1994
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
8
Review Days
269
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Basic Information
- Device Name
- UROPAPER EIKEN 6B
- K Number
- K932368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tanabe U.S.A., Inc.
- Date Received
- April 19, 1993
- Decision Date
- January 13, 1994
- Product Code
- JIL
- 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 |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
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Other Clearances by Tanabe U.S.A., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932366 | UROPAPER EIKEN HAG | Nov 26, 1993 | Substantially Equivalent |
| K932365 | UROPAPER EIKEN AG | Nov 26, 1993 | Substantially Equivalent |
| K932367 | UROPAPER EIKEN 8 | Nov 16, 1993 | Substantially Equivalent |
| K931897 | UROPAPER | Nov 16, 1993 | Substantially Equivalent |
| K932369 | UROPAPER EIKEN 7 | Nov 16, 1993 | Substantially Equivalent |
| K932364 | UROPAPER EIKEN GP | Nov 16, 1993 | Substantially Equivalent |
| K932363 | UROPAPER EIKEN GK | Nov 16, 1993 | Substantially Equivalent |