SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
FDA 510(k) clearance K971534 · decided 1997-05-21
Clearance details
- K-number
- K971534
- Device name
- SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
- Applicant
- Beckman
- Decision
- Substantially Equivalent
- Date received
- 1997-04-28
- Decision date
- 1997-05-21
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- DIF
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.