FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K Number: K913130
·
Decision Sep 27, 1991
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
505
Review Days
73
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Basic Information
- Device Name
- STRATUS IINTELLECT IMMUNOASSAY SYSTEM
- K Number
- K913130
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corp
- Date Received
- July 16, 1991
- Decision Date
- September 27, 1991
- Product Code
- KHO
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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