FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUTEX SLE LATEX TEST
K Number: K924248
·
Decision Nov 2, 1992
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
18
Review Days
70
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Basic Information
- Device Name
- ACCUTEX SLE LATEX TEST
- K Number
- K924248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J.S. Medical Assoc.
- Date Received
- August 24, 1992
- Decision Date
- November 2, 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 J.S. Medical Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K932752 | VISI-SPOT | Nov 5, 1993 | Substantially Equivalent |
| K932688 | EYE SPOT IM TEST | Sep 8, 1993 | Substantially Equivalent |
| K932180 | EYE SPOT CRP TEST | Aug 23, 1993 | Substantially Equivalent |
| K932551 | ACCUTEX IM LATEX TEST | Aug 9, 1993 | Substantially Equivalent |
| K926112 | ACCUTEX BETA-HCG TEST | Jul 28, 1993 | Substantially Equivalent |
| K924332 | ACCUTEX CRP LATEX TEST | Dec 7, 1992 | Substantially Equivalent |
| K924247 | ACCUTEX ASO LATEX TEST | Dec 7, 1992 | Substantially Equivalent |
| K924036 | ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST | Dec 1, 1992 | Substantially Equivalent |
| K924037 | ACCUTEX IM RBC TEST | Nov 2, 1992 | Substantially Equivalent |
| K912717 | J&S UIBC REAGENTS | Sep 25, 1991 | Substantially Equivalent |