FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREGNAGEN 1-STEP PREGNANCY TEST
K Number: K925189
·
Decision Jan 6, 1993
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
12
Review Days
85
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Basic Information
- Device Name
- PREGNAGEN 1-STEP PREGNANCY TEST
- K Number
- K925189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biogenex Laboratories
- Date Received
- October 13, 1992
- Decision Date
- January 6, 1993
- Product Code
- LCX
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
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Other Clearances by Biogenex Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | Mar 8, 2002 | Substantially Equivalent |
| K013148 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) | Feb 28, 2002 | Substantially Equivalent |
| K902208 | MODIFIED OVUGEN | Jul 17, 1990 | Substantially Equivalent |
| K884880 | PREGNAGEN(TM) | Jan 13, 1989 | Substantially Equivalent |
| K882002 | PREGNAGEN(TM) | Sep 9, 1988 | Substantially Equivalent |
| K873534 | OVUGEN SURETEST | Nov 23, 1987 | Substantially Equivalent |
| K831221 | RIAGEN B-HCG RIA KIT | Jun 2, 1983 | Substantially Equivalent |
| K821657 | RIAGEN B-HCG RIA | Jul 13, 1982 | Substantially Equivalent |
| K821234 | RIAGEN B-HCG RIA | May 21, 1982 | Substantially Equivalent |
| K820724 | FLUOROGEN PAP FIA | Apr 14, 1982 | Substantially Equivalent |