HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
FDA 510(k) clearance K890957 · decided 1989-03-09
Clearance details
- K-number
- K890957
- Device name
- HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
- Applicant
- Hycor Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-27
- Decision date
- 1989-03-09
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- DIF
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Garden Grove, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.