FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT
K Number: K914853
·
Decision Jan 15, 1992
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
2
Review Days
79
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Basic Information
- Device Name
- ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT
- K Number
- K914853
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reads Medical Products, Inc.
- Date Received
- October 28, 1991
- Decision Date
- January 15, 1992
- Product Code
- LJM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
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Other Clearances by Reads Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914405 | READS(R) IGA ANTI-CARDIOLIPIN TEST KIT | Dec 18, 1991 | Substantially Equivalent |