NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
FDA 510(k) clearance K013992 · decided 2001-12-13
Clearance details
- K-number
- K013992
- Device name
- NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
- Applicant
- Nichols Institute Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2001-12-04
- Decision date
- 2001-12-13
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- CEW
- Device class
- 2
- Regulation number
- 862.1545
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Juan Capistrano, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.