FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ECLIPSE ICA ANALYZER
K Number: K910302
·
Decision Feb 22, 1991
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
7
Review Days
29
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Basic Information
- Device Name
- ECLIPSE ICA ANALYZER
- K Number
- K910302
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biotope, Inc.
- Date Received
- January 24, 1991
- Decision Date
- February 22, 1991
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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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 |
| 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 |