CORTISOL REAGENT SYSTEM
FDA 510(k) clearance K760939 · decided 1976-11-16
Clearance details
- K-number
- K760939
- Device name
- CORTISOL REAGENT SYSTEM
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-11-01
- Decision date
- 1976-11-16
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- CGR
- Device class
- 2
- Regulation number
- 862.1205
- 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.