COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
FDA 510(k) clearance K022288 · decided 2002-12-17
Clearance details
- K-number
- K022288
- Device name
- COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
- Applicant
- Bayer Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-15
- Decision date
- 2002-12-17
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- LTJ
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Atellica IM Total PSA II (tPSAII) (K251630) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 |
| FREND PSA PLUS (reagent cartridge) (K162378) | Nanoentek USA, Inc. | 2017-05-17 |
| FREND PSA PLUS (REAGENT CARTRIDGE) (K124056) | Nanoentek, Inc. | 2013-05-29 |
| TPSA FLEX REAGENT CARTRIDGE (K031343) | Dade Behring, Inc. | 2003-05-15 |
| PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022177) | Bayer Diagnostics Corp. | 2002-12-17 |
| VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 (K010550) | bioMerieux, Inc. | 2001-04-24 |
| DIMENSION PSA FLEX REAGENT CARTRIDGE (K003963) | Dade Behring, Inc. | 2001-02-28 |
| ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (K002376) | Bayer Corp. | 2000-10-26 |
| FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER (K003094) | Qualigen, Inc. | 2000-10-25 |
| TOTAL PSA MICROTITER ELISA (K002121) | Oncogene Science, Inc. | 2000-08-30 |
| COMPLEXED PSA MICROTITER ELISA (K002313) | Oncogene Science, Inc. | 2000-08-30 |
| FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM (K994419) | Qualisys Diagnostics, Inc. | 2000-06-28 |
Recalls involving this device
No recalls on record reference this clearance.