FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRE-DENT
K Number: K791200
·
Decision Aug 10, 1979
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
38
Applicant Total
1
Review Days
43
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Basic Information
- Device Name
- PRE-DENT
- K Number
- K791200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Fichte, Graves, and Hunt
- Date Received
- June 28, 1979
- Decision Date
- August 10, 1979
- Product Code
- GIM
- 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 |
|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | FDA class 2 | Clinical Chemistry |
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