HORMONE KIT, PARATHYROID
FDA 510(k) clearance K782010 · decided 1979-01-10
Clearance details
- K-number
- K782010
- Device name
- HORMONE KIT, PARATHYROID
- Applicant
- Nichols Institute Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1978-12-01
- Decision date
- 1979-01-10
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- CEW
- Device class
- 2
- Regulation number
- 862.1545
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.