NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
FDA 510(k) clearance K932406 · decided 1993-12-02
Clearance details
- K-number
- K932406
- Device name
- NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
- Applicant
- Nuclear Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-13
- Decision date
- 1993-12-02
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- JNO
- Device class
- 1
- Regulation number
- 862.1725
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.