FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST
K Number: K925355
·
Decision Jul 12, 1994
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
14
Review Days
628
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Basic Information
- Device Name
- BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST
- K Number
- K925355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Princeton Biomedix
- Date Received
- October 22, 1992
- Decision Date
- July 12, 1994
- Product Code
- LFX
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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Other Clearances by Princeton Biomedix
| K Number | Device Name | ||
|---|---|---|---|
| K942052 | LIFESIGN MI MYOGLOBIN | Feb 7, 1995 | Substantially Equivalent |
| K930185 | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP | Mar 4, 1993 | Substantially Equivalent |
| K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST | Feb 23, 1993 | Substantially Equivalent |
| K926308 | LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST | Jan 26, 1993 | Substantially Equivalent |
| K901011 | BIOSIGN HCG-ONE STEP PREGNANCY TEST | May 4, 1990 | Substantially Equivalent |
| K894705 | BIOSPOT HCG-RAPID PREGNANCY TEST | Oct 18, 1989 | Substantially Equivalent |
| K894750 | BIOSTIX I. HCG - ONE STEP PREGNANCY TEST | Oct 18, 1989 | Substantially Equivalent |
| K892654 | BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST | Jun 19, 1989 | Substantially Equivalent |
| K761315 | ALKALINE PHOSPHATASE (ALP)/PNPP | Feb 24, 1977 | Substantially Equivalent |
| K760345 | TEST, LACTATE DEHYDROGENASE | Oct 27, 1976 | Substantially Equivalent |