FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
VMA EIA KIT YAMASA
K Number: K895287
·
Decision Oct 30, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
11
Applicant Total
2
Review Days
66
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Basic Information
- Device Name
- VMA EIA KIT YAMASA
- K Number
- K895287
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1795
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Yamasa Shoy Co., Ltd.
- Date Received
- August 25, 1989
- Decision Date
- October 30, 1989
- Product Code
- CDF
- 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 |
|---|---|---|---|
| CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | FDA class 1 | Clinical Chemistry |
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Other Clearances by Yamasa Shoy Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K895288 | HVA EIA KIT YAMASA | Oct 31, 1989 | Substantially Equivalent |