FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECI-MIX
K Number: K771617
·
Decision Sep 2, 1977
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
4
Applicant Total
4
Review Days
9
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Basic Information
- Device Name
- SPECI-MIX
- K Number
- K771617
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Thermolyne Corp.
- Date Received
- August 24, 1977
- Decision Date
- September 2, 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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