SICKLE-CHEX
FDA 510(k) clearance K852107 · decided 1985-07-05
Clearance details
- K-number
- K852107
- Device name
- SICKLE-CHEX
- Applicant
- Streck Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-15
- Decision date
- 1985-07-05
- Days to decision
- 51 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Omaha, NE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.