510(k) K913122
K913122 is an FDA 510(k) premarket notification submitted by Quidel Corp. for the device "DIRECTIGEN 1-2-3(TM) HCG TEST". The FDA issued a decision of Substantially Equivalent on August 16, 1991. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Quidel Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1991
- Date Received
- July 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Visual, Pregnancy Hcg, Prescription Use
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type