510(k) Premarket Notification

• Device Classification Name: Kit, Test, Pregnancy, Hcg, Over The Counter
• 510(k) Number: K041273
• Device Name: ONE-STEP PREGNANCY TEST
• Applicant: W.H.P.M., INC.; 163 CABOT ST.; BEVERLY, MA 01915
• Applicant Contact: FRAN WHITE
• Correspondent: W.H.P.M., INC.; 163 CABOT ST.; BEVERLY, MA 01915
• Correspondent Contact: FRAN WHITE
• Regulation Number: 862.1155
• Classification Product Code: LCX
• Date Received: 05/12/2004
• Decision Date: 05/20/2004
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Clinical Chemistry
• 510k Review Panel: Clinical Chemistry
• Summary: Summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No