FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K Number: K980376
·
Decision Apr 23, 1998
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
33
Applicant Total
96
Review Days
83
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
- THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K Number
- K980376
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- January 30, 1998
- Decision Date
- April 23, 1998
- 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
Other Clearances by Bayer Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K024062 | ASCENSIA BREEZE BLOOD GLUCOSE METER | Mar 3, 2003 | Substantially Equivalent |
| K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST | Feb 11, 2003 | Substantially Equivalent |
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | Jan 30, 2003 | Substantially Equivalent |
| K024234 | ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL | Jan 23, 2003 | Substantially Equivalent |
| K022288 | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Dec 17, 2002 | Substantially Equivalent |
| K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM | Nov 20, 2002 | Substantially Equivalent |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Jul 24, 2002 | Substantially Equivalent |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | Jul 5, 2002 | Substantially Equivalent |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Mar 27, 2002 | Substantially Equivalent |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Dec 21, 2001 | Substantially Equivalent |