FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K Number: K910249
·
Decision Feb 13, 1991
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
49
Applicant Total
505
Review Days
22
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Basic Information
- Device Name
- STRATUS ESTRADIOL FLUOREMETRIC ENZYME
- K Number
- K910249
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Baxter Healthcare Corp
- Date Received
- January 22, 1991
- Decision Date
- February 13, 1991
- Product Code
- CHP
- 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 |
|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHP), ordered by most recent decision date.
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FDA 510(k)
FDA Class 1
·Clinical Chemistry
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