OCTEIA INTACT PTH
FDA 510(k) clearance K941878 · decided 1994-09-07
Clearance details
- K-number
- K941878
- Device name
- OCTEIA INTACT PTH
- Applicant
- I.D.S.
- Decision
- Substantially Equivalent
- Date received
- 1994-04-18
- Decision date
- 1994-09-07
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- CEW
- Device class
- 2
- Regulation number
- 862.1545
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tyne & Wear, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.