FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
K Number: K930185
·
Decision Mar 4, 1993
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
14
Review Days
49
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Basic Information
- Device Name
- OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
- K Number
- K930185
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Princeton Biomedix
- Date Received
- January 14, 1993
- Decision Date
- March 4, 1993
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Princeton Biomedix
| K Number | Device Name | ||
|---|---|---|---|
| K942052 | LIFESIGN MI MYOGLOBIN | Feb 7, 1995 | Substantially Equivalent |
| K925355 | BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST | Jul 12, 1994 | 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 |