510(k) K922290
K922290 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "SINGLE-STEP PREGNANCY, HCG TEST". The FDA issued a decision of Substantially Equivalent on Jul 9, 1992. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. American Medical Products, Inc. has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 9, 1992
- Date Received
- May 15, 1992
- 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
- 510(k)