FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
K Number: K924036
·
Decision Dec 1, 1992
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
18
Review Days
112
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Basic Information
- Device Name
- ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
- K Number
- K924036
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J.S. Medical Assoc.
- Date Received
- August 11, 1992
- Decision Date
- December 1, 1992
- Product Code
- DHR
- 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 |
|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHR), ordered by most recent decision date.
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ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
FDA 510(k)
FDA Class 2
·Immunology
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 |
| K924037 | ACCUTEX IM RBC TEST | Nov 2, 1992 | Substantially Equivalent |
| K924248 | ACCUTEX SLE LATEX TEST | Nov 2, 1992 | Substantially Equivalent |
| K912717 | J&S UIBC REAGENTS | Sep 25, 1991 | Substantially Equivalent |