FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
VTEC-RPLA SEIKEN
K Number: K981734
·
Decision Sep 22, 1998
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
11
Applicant Total
4
Review Days
127
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Basic Information
- Device Name
- VTEC-RPLA SEIKEN
- K Number
- K981734
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3255
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Denka Seiken'S
- Date Received
- May 18, 1998
- Decision Date
- September 22, 1998
- Product Code
- GNA
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GNA | Antisera, All Types, Escherichia Coli | FDA class 1 | Microbiology |
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