ANI BIOCARD HCG TEST
FDA 510(k) clearance K923030 · decided 1992-09-15
Clearance details
- K-number
- K923030
- Device name
- ANI BIOCARD HCG TEST
- Applicant
- Ani OY
- Decision
- Substantially Equivalent
- Date received
- 1992-06-23
- Decision date
- 1992-09-15
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Canada M1x 1b4, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.