ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
FDA 510(k) clearance K051733 · decided 2005-12-07
Clearance details
- K-number
- K051733
- Device name
- ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
- Applicant
- Drg Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-28
- Decision date
- 2005-12-07
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- NHG
- Device class
- 2
- Regulation number
- 862.1205
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Stroudsburg, PA, 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 |
|---|---|---|
| Cortisol Saliva Luminescence Immunoassay (K150528) | Ibl International GmbH | 2015-11-25 |
| PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (K102841) | Pantex, Div. Bio-Analysis, Inc. | 2012-05-08 |
| ELECSYS CORTISOL TEST SYSTEM (K070788) | Roche Diagnostics | 2007-10-05 |
| ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE (K043175) | Roche Diagnostics Corp. | 2004-11-24 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY (K031348) | Salimetrics, LLC | 2003-06-10 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 (K011323) | Salimetrics, LLC | 2001-12-17 |
Recalls involving this device
No recalls on record reference this clearance.