QUICKSCREEN ONE STEP PCP SCREENING TEST
FDA 510(k) clearance K974582 · decided 1998-02-04
Clearance details
- K-number
- K974582
- Device name
- QUICKSCREEN ONE STEP PCP SCREENING TEST
- Applicant
- Phamatech
- Decision
- Substantially Equivalent
- Date received
- 1997-12-08
- Decision date
- 1998-02-04
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- LCM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.