FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLATELET AGITATOR
K Number: K770830
·
Decision Jul 11, 1977
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
4
Applicant Total
3
Review Days
66
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Basic Information
- Device Name
- PLATELET AGITATOR
- K Number
- K770830
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Helmer Labs, Inc.
- Date Received
- May 6, 1977
- Decision Date
- July 11, 1977
- Product Code
- GLE
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GLE | Mixer, Blood Tube | FDA class 1 | Clinical Chemistry |
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