ACS CORTISOL IMMUNOASSAY
FDA 510(k) clearance K962559 · decided 1996-11-05
Clearance details
- K-number
- K962559
- Device name
- ACS CORTISOL IMMUNOASSAY
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-01
- Decision date
- 1996-11-05
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- JFT
- Device class
- 2
- Regulation number
- 862.1205
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Elecsys Cortisol III (K242505) | Roche Diagnostics | 2025-07-17 |
| ADVIA Centaur Cortisol (COR) (K192788) | Siemens Healthcare Diagnostics, Inc. | 2019-11-25 |
| Elecsys Cortisol II, Cortisol II CalSet (K152227) | Roche Diagnostics | 2016-04-27 |
| ADVIA Centaur Cortisol (COR) Assy (K142723) | Siemens Healthcare Diagnostics, Inc. | 2015-03-31 |
| ARCHITECT CORTISOL ASSAY (K062204) | Seradyn, Inc. | 2006-09-22 |
| AXSYM CORTISOL ASSAY (K033731) | Fujirebio Diagnostics,Inc. | 2004-02-20 |
| ELECSYS CORTISOL TEST SYSTEM (K021218) | Roche Diagnostics Corp. | 2002-09-09 |
| AIA-PACK CORT ASSAY (K954591) | Tosoh Medics, Inc. | 1995-12-15 |
| CIDBA CORNING ACS CORTISOL IMMUNOASSAY (K934317) | Ciba Corning Diagnostics Corp. | 1994-05-13 |
| DELFIA CORTISOL KIT (K930732) | Wallac OY | 1993-07-27 |
| VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT (K931031) | Biomerieux Vitek, Inc. | 1993-07-27 |
| ACCESS(R) CORTISOL REAGENTS (K926322) | Bio-Rad Laboratories, Inc. | 1993-05-26 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Materi recall (Z-1505-2023) | Siemens Healthcare Diagnostics, Inc. | 2023-05-03 |
| Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 0461004 recall (Z-1390-2012) | Siemens Healthcare Diagnostics, Inc | 2012-04-09 |