FIRST SIGN DRUG OF ABUSE SCREENING TEST
FDA 510(k) clearance K032575 · decided 2004-05-19
Clearance details
- K-number
- K032575
- Device name
- FIRST SIGN DRUG OF ABUSE SCREENING TEST
- Applicant
- W.H.P.M., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-20
- Decision date
- 2004-05-19
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- DKZ
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.