URINARY 17-KETOSTERIOD/17
FDA 510(k) clearance K772337 · decided 1978-01-12
Clearance details
- K-number
- K772337
- Device name
- URINARY 17-KETOSTERIOD/17
- Applicant
- Eppendorf-Brinkmann, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-22
- Decision date
- 1978-01-12
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- CDG
- Device class
- 1
- Regulation number
- 862.1385
- 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.