First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
FDA 510(k) clearance K210327 · decided 2021-08-12
Clearance details
- K-number
- K210327
- Device name
- First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
- Applicant
- W.H.P.M., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-04
- Decision date
- 2021-08-12
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- QBF
- Device class
- 2
- Regulation number
- 862.3700
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Irwindale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.