FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT
K Number: K952287
·
Decision Dec 18, 1995
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
93
Applicant Total
4
Review Days
216
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Basic Information
- Device Name
- REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT
- K Number
- K952287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reaads Medical Products, Inc.
- Date Received
- May 16, 1995
- Decision Date
- December 18, 1995
- Product Code
- MID
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | FDA class 2 | Immunology |
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