FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERPES 1 AND 2 MICROASSAYS
K Number: K871420
·
Decision Dec 11, 1987
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
39
Applicant Total
68
Review Days
247
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Basic Information
- Device Name
- HERPES 1 AND 2 MICROASSAYS
- K Number
- K871420
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Diamedix Corp.
- Date Received
- April 8, 1987
- Decision Date
- December 11, 1987
- Product Code
- GGC
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| GGC | Control, Plasma, Abnormal | FDA class 2 | Hematology |
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