FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OVUGEN SURETEST
K Number: K873534
·
Decision Nov 23, 1987
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
12
Review Days
83
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Basic Information
- Device Name
- OVUGEN SURETEST
- K Number
- K873534
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biogenex Laboratories
- Date Received
- September 1, 1987
- Decision Date
- November 23, 1987
- 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 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 |
| K925189 | PREGNAGEN 1-STEP PREGNANCY TEST | Jan 6, 1993 | 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 |
| 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 |