NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
FDA 510(k) clearance K962601 · decided 1996-12-24
Clearance details
- K-number
- K962601
- Device name
- NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
- Applicant
- Nichols Institute Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1996-07-02
- Decision date
- 1996-12-24
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- CKG
- Device class
- 2
- Regulation number
- 862.1025
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Juan Capistrano, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nichols Advantage ACTH Test System, catalog number 62-7004. recall (Z-1044-05) | Nichols Institute Diagnostics | 2005-07-28 |