FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KETOREX C SANWA
K Number: K953452
·
Decision May 2, 1996
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
15
Applicant Total
5
Review Days
289
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Basic Information
- Device Name
- KETOREX C SANWA
- K Number
- K953452
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1380
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ihara Medics U.S., Inc.
- Date Received
- July 18, 1995
- Decision Date
- May 2, 1996
- Product Code
- JMK
- 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 |
|---|---|---|---|
| JMK | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | FDA class 1 | Clinical Chemistry |
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