KETOSTEROID TEST, HYCEL-17
FDA 510(k) clearance K782116 · decided 1979-01-26
Clearance details
- K-number
- K782116
- Device name
- KETOSTEROID TEST, HYCEL-17
- Applicant
- Hycel, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-12-27
- Decision date
- 1979-01-26
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- CCY
- Device class
- 1
- Regulation number
- 862.1430
- 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.