FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUTEX BETA-HCG TEST
K Number: K926112
·
Decision Jul 28, 1993
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
18
Review Days
237
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Basic Information
- Device Name
- ACCUTEX BETA-HCG TEST
- K Number
- K926112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- J.S. Medical Assoc.
- Date Received
- December 3, 1992
- Decision Date
- July 28, 1993
- Product Code
- JHJ
- 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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Other Clearances by J.S. Medical Assoc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| 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 |
| K924248 | ACCUTEX SLE LATEX TEST | Nov 2, 1992 | Substantially Equivalent |
| K912717 | J&S UIBC REAGENTS | Sep 25, 1991 | Substantially Equivalent |