QUICKCARD PRO HCG TEST, MODEL 9008
FDA 510(k) clearance K980896 · decided 1998-04-02
Clearance details
- K-number
- K980896
- Device name
- QUICKCARD PRO HCG TEST, MODEL 9008
- Applicant
- Phamatech
- Decision
- Substantially Equivalent
- Date received
- 1998-03-09
- Decision date
- 1998-04-02
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.