FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
K Number: K000566
·
Decision Mar 9, 2000
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
32
Applicant Total
104
Review Days
16
Basic Information
- Device Name
- MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
- K Number
- K000566
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date Received
- February 22, 2000
- Decision Date
- March 9, 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.
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
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
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
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Ortho-Clinical Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | May 5, 2023 | Unknown |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | May 5, 2023 | Unknown |
| K210858 | VITROS Chemistry Products PHBR Slides | Aug 13, 2021 | Substantially Equivalent |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | Jun 7, 2019 | Substantially Equivalent |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Apr 26, 2019 | Substantially Equivalent |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Apr 3, 2019 | Substantially Equivalent |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Mar 27, 2019 | Substantially Equivalent |
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Mar 14, 2019 | Substantially Equivalent |
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | Oct 30, 2018 | Substantially Equivalent |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | Oct 30, 2018 | Substantially Equivalent |