FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ECLIPSE ICA CHOLESTEROL
K Number: K905145
·
Decision Feb 26, 1991
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
7
Review Days
103
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Basic Information
- Device Name
- ECLIPSE ICA CHOLESTEROL
- K Number
- K905145
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotope, Inc.
- Date Received
- November 15, 1990
- Decision Date
- February 26, 1991
- Product Code
- CHH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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Other Clearances by Biotope, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910256 | ECLIPSE ICA TSH | Feb 22, 1991 | Substantially Equivalent |
| K910302 | ECLIPSE ICA ANALYZER | Feb 22, 1991 | Substantially Equivalent |
| K905601 | ECLIPSE ICA TRIGLYCERIDES | Jan 17, 1991 | Substantially Equivalent |
| K905719 | ECLIPSE ICA DIGOXIN | Jan 17, 1991 | Substantially Equivalent |
| K905602 | ECLIPSE ICA BUN | Jan 16, 1991 | Substantially Equivalent |
| K905144 | ECLIPSE ICA GLUCOSE | Jan 4, 1991 | Substantially Equivalent |