FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SR-PLUS DIRECT CHOLESTEROL TEST
K Number: K780545
·
Decision May 26, 1978
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
10
Applicant Total
47
Review Days
53
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Basic Information
- Device Name
- SR-PLUS DIRECT CHOLESTEROL TEST
- K Number
- K780545
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Stanbio Laboratory
- Date Received
- April 3, 1978
- Decision Date
- May 26, 1978
- Product Code
- CGO
- 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 |
|---|---|---|---|
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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ALPHA/CHOL
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