TOTAL PSA MICROTITER ELISA— 510(k) K002121
Substantially EquivalentOncogene Science, Inc.
FDA 510(k) clearance K002121 for TOTAL PSA MICROTITER ELISA, Substantially Equivalent on 2000-08-30. Applicant: Oncogene Science, Inc.. Device class: 2.
Clearance details
- Applicant
- Oncogene Science, Inc.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Recent devices under product code LTJ
view allMore clearances from Oncogene Science, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.