FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL PSA MICROTITER ELISA
K Number: K002121
·
Decision Aug 30, 2000
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
33
Applicant Total
3
Review Days
48
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TOTAL PSA MICROTITER ELISA
- K Number
- K002121
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oncogene Science, Inc.
- Date Received
- July 13, 2000
- Decision Date
- August 30, 2000
- Product Code
- LTJ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LTJ), ordered by most recent decision date.
Atellica IM Total PSA II (tPSAII)
FDA 510(k)
FDA Class 2
·Immunology
FREND PSA PLUS (reagent cartridge)
FDA 510(k)
FDA Class 2
·Immunology
FREND PSA PLUS (REAGENT CARTRIDGE)
FDA 510(k)
FDA Class 2
·Immunology
TPSA FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Immunology
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Immunology