FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ECLIPSE ICA TRIGLYCERIDES
K Number: K905601
·
Decision Jan 17, 1991
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
150
Applicant Total
7
Review Days
35
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Basic Information
- Device Name
- ECLIPSE ICA TRIGLYCERIDES
- K Number
- K905601
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotope, Inc.
- Date Received
- December 13, 1990
- Decision Date
- January 17, 1991
- Product Code
- CDT
- 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDT), ordered by most recent decision date.
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Other Clearances by Biotope, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905145 | ECLIPSE ICA CHOLESTEROL | Feb 26, 1991 | Substantially Equivalent |
| K910256 | ECLIPSE ICA TSH | Feb 22, 1991 | Substantially Equivalent |
| K910302 | ECLIPSE ICA ANALYZER | Feb 22, 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 |